3M Company
Medical device manufacturer in Saint Paul, MN.
330510(k) clearances
1PMA approvals
2recalls
Device types
- FRC Indicator, Biological Sterilization Process 31
- JOJ Indicator, Physical/Chemical Sterilization… 24
- EBF Material, Tooth Shade, Resin 18
- ESD Hearing Aid, Air-Conduction, Prescription 16
- DHB System, Test, Radioallergosorbent (Rast)… 13
- EMA Cement, Dental 12
- FRO Dressing, Wound, Drug 10
- FRN Pump, Infusion 8
- FXX Mask, Surgical 6
- DQD Stethoscope, Electronic 6
- KGX Tape And Bandage, Adhesive 6
- KLE Agent, Tooth Bonding, Resin 5
- GXY Electrode, Cutaneous 5
- KMF Bandage, Liquid 5
- ELW Material, Impression 5
- GEI Electrosurgical, Cutting & Coagulation &… 4
- LWM Device, Electrical Dental Anesthesia 4
- KKX Drape, Surgical, Antimicrobial 4
- IXW Processor, Radiographic-Film, Automatic 4
- KWY Prosthesis, Hip, Hemi-, Femoral… 4
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 01/28/2025SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
| K211705 | 3M Attest Rapid Readout Biological Indicator, 1295FRC · Special | 06/28/2022SE |
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)JOJ · Special | 06/24/2022SE |
| K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape…JOJ · Traditional | 05/23/2022SE |
| K220507 | 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, LargePZW · Traditional | 05/23/2022SE |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKM · Traditional | 04/20/2022SE |
| K213809 | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge…FRC · Traditional | 04/06/2022SE |
| K212081 | 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228JOJ · Special | 09/05/2021SE |
| K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate InsulationDWJ · Traditional | 04/29/2021SE |
| K210603 | 3M Bair Hugger Temperature Management System (Model 675)DWJ · Special | 03/30/2021SE |
| K210277 | 3M Attest Rapid Readout Biological Indicator, 1295FRC · Special | 03/03/2021SE |
| K203458 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Special | 12/11/2020SE |
| K200996 | 3M Attest Rapid Readout Biological IndicatorFRC · Traditional | 12/11/2020SE |
| K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228JOJ · Special | 12/10/2020SE |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical IndicatorQKM · Special | 12/07/2020SE |
| K200299 | Curos Jet Disinfecting CapQBP · Traditional | 10/29/2020SE |
| K200835 | 3M Tegaderm CHG Chlorhexidine Gluconate Gel PadFRO · Traditional | 09/04/2020SE |
| K200766 | 3M Attest Steam Chemical Integrator Test PackFRC · Traditional | 07/02/2020SE |
| K192550 | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid…FRC · Traditional | 06/05/2020SE |
| K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge PackFRC · Traditional | 02/07/2020SE |
| K193254 | 3M Attest Steam Chemical IntegratorJOJ · Special | 12/23/2019SE |
| K191236 | 3M Attest Steam Chemical IntegratorsJOJ · Traditional | 11/22/2019SE |
| K192937 | 3M Comply Hydrogen Peroxide Chemical IndicatorJOJ · Special | 11/16/2019SE |
| K192673 | 3M Comply Hydrogen Peroxide Indicator Tape 1228JOJ · Special | 10/28/2019SE |
| K192119 | 3M Clarity AlignersNXC · Traditional | 09/05/2019SE |
| K183211 | 3M Comply Hydrogen Peroxide Chemical IndicatorJOJ · Traditional | 02/26/2019SE |
| K183209 | 3M Comply Hydrogen Peroxide Indicator TapeJOJ · Traditional | 02/15/2019SE |
| K183159 | 3M Clarity AlignersNXC · Traditional | 11/26/2018SE |
| K173519 | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus…FRC · Traditional | 04/23/2018SE |
| K173437 | 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M…FRC · Traditional | 03/19/2018SE |
| K173435 | 3M Attest Rapid Readout Biological IndicatorFRC · Traditional | 02/09/2018SE |
| K173584 | 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest…FRC · Traditional | 01/22/2018SE |
| K171373 | 3M Bair Hugger Model 675 Total Temperature Management SystemDWJ · Traditional | 10/10/2017SE |
| K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 08/14/2017SE |
| K170563 | 3M Comply Hydrogen Peroxide Indicator TapeJOJ · Traditional | 07/27/2017SE |
| K171003 | 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-readerFRC · Traditional | 07/21/2017SE |
| K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement DressingSEL · Special | 07/11/2017SE |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement DressingSEL · Traditional | 05/15/2017SE |
| K170330 | 3M Protemp Cement Temporary Dental CementEMA · Traditional | 02/06/2017SE |
| K163207 | Filtek One Bulk Fill RestorativeEBF · Traditional | 11/28/2016SE |
| K160546 | 3M Attest Rapid Readout Biological IndicatorFRC · Traditional | 06/09/2016SE |
| K152060 | 3M Attest Rapid Readout Biological Indicator 1295FRC · Traditional | 12/01/2015SE |
| K150694 | 3M Comply Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 10/01/2015SE |
| K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 09/29/2015SE |
| K151302 | Clinpro VarnishLBH · Traditional | 09/18/2015SE |
| K150477 | 3M Comply Indicator Tape for Ethylene Oxide (EO) SterilizationJOJ · Traditional | 07/02/2015SE |
| K142034 | 3M Steri-Vac Sterilizer/AeratorFLF · Abbreviated | 01/08/2015SE |
| K140392 | 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-ReaderFRC · Traditional | 08/13/2014SE |
| K123546 | 3M Attest(Tm) Auto-ReaderFRC · Traditional | 03/18/2013SE |
| K121593 | 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest(Tm) Super Rapid 5…FRC · Traditional | 03/15/2013SE |
| K123679 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Port DressingFRO · Traditional | 02/28/2013SE |
| K121069 | 3M Vflex Health Care Particulate Respirator and Surgical MaskMSH · Traditional | 02/11/2013SE |
| K123085 | Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings…DWL · Traditional | 12/20/2012SE |
| K122467 | 3M True Definition ScannerNOF · Traditional | 11/20/2012SE |
| K121484 | 3M Attest(Tm) Super Rapid Readout Biological Indicator, 3M Attest(Tm) Auto-ReaderFRC · Traditional | 10/19/2012SE |
| K122569 | Lava Ultimate Cad/Cam Restorative for Cerec Lava Ultimate Cad/Cam Restorative for E4D…EBF · Traditional | 09/12/2012SE |
| K120704 | 3M Littmann Telesteth Online Ausculation SystemDRG · Traditional | 05/03/2012SE |
| K110457 | 3M Tegaderm Matrix DressingFRO · Traditional | 12/07/2011SE |
| K101468 | 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced…FYA · Traditional | 04/14/2011SE |
| K101910 | 3M Attest Rapid Readout Steam Process Challenge Device, Model 1296V, 3M Attest Rapid…FRC · Traditional | 12/08/2010SE |
| K101528 | 3M Comply Lead Free Process Indicators for SteamJOJ · Traditional | 10/01/2010SE |
| K101249 | Sterigage Model 1243RA, 1243RB, 1243REJOJ · Traditional | 09/08/2010SE |
| K101834 | 3M Littmann Scope-To Scope Software SystemDRG · Traditional | 09/03/2010SE |
| K100235 | Filtek Supreme Ultra Flowable RestorativeEBF · Traditional | 05/12/2010SE |
| K093199 | 3M Comply Bowie- Dick Type Lead Free Test PackJOJ · Special | 12/04/2009SE |
| K091632 | SPK SealantEBC · Traditional | 09/03/2009SE |
| K083903 | 3M Littmann Electronic Stethoscope, Model 3200DQD · Traditional | 07/15/2009SE |
| K090569 | Modification to: Attest Rapid Readout Biological Indicator, Mode 1292FRC · Special | 04/29/2009SE |
| K090519 | Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride…LBH · Special | 04/15/2009SE |
| K083610 | Filtek Supreme Ultra Universal RestorativeEBF · Traditional | 12/17/2008SE |
| K072733 | 3M Espe Adult CrownEBF · Traditional | 02/15/2008SE |
| K063458 | 3M Tegaderm CHG DressingFRO · Traditional | 04/05/2007SE |
| K063023 | 3M Health Care Particulate Respirator and Surgical Mask, Model 1870MSH · Abbreviated | 02/23/2007SE |
| K053409 | 3M Liquid BandageKMF · Traditional | 06/19/2006SE |
| K053256 | 3M Tegaderm Silver (AG) MeshFRO · Special | 12/16/2005SE |
| K052235 | LCREMA · Special | 09/27/2005SE |
| K052128 | 3M Attest 293 Auto-Reader, 3M Attest 293G Auto-ReaderFRC · Special | 08/16/2005SE |
| K051790 | 3M Littmann Electronic Stethoscope, Model 4100DQD · Special | 07/25/2005SE |
| K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000DQD · Special | 02/22/2005SE |
| K040890 | 3M Tegaderm SilverFRO · Traditional | 11/02/2004SE |
| K041934 | 3M Littmann Electronic Stethoscope, Model 3000DQD · Traditional | 10/15/2004SE |
| K031012 | Attest Rapid Readout Biological Indicator for Eo, Model 1294; Attest Rapid Readout…FRC · Traditional | 10/16/2003SE |
| K031263 | 3M Liquid Bandage, Model 120-LBKMF · Traditional | 10/07/2003SE |
| K031287 | Steri-Drape Surgical DrapesKKX · Traditional | 09/10/2003SE |
| K022476 | Relyx RmgipEMA · Special | 08/02/2002SE |
| K020589 | 3M Comply 1228 Gas Plasma Indicator TapeJOJ · Traditional | 04/22/2002SE |
| K004009 | 3M Attest 290 Auto-ReaderFRC · Traditional | 03/25/2002SE |
| K011200 | Gilb, Model 8010EMA · Traditional | 06/14/2001SE |
| K011167 | XseKLE · Traditional | 05/17/2001SE |
| K010781 | 3M Espe HaurEBF · Traditional | 04/13/2001SE |
| K003723 | 3M LittmannDQD · Abbreviated | 03/27/2001SE |
| K002452 | 3M Rely X Veneer Cement Try-In PasterEMA · Traditional | 09/28/2000SE |
| K001114 | 3M Quik Temp Temporization MaterialEBG · Traditional | 06/09/2000SE |
| K992489 | 3M TR SystemEIH · Traditional | 01/11/2000SE |
| K992326 | 3M Clinpro SealantEBC · Traditional | 10/08/1999SE |
| K991961 | 3M LVR SystemEBF · Traditional | 08/09/1999SE |
| K982893 | 3M Tegasorb Hydrocolloid DressingKMF · Traditional | 10/26/1998SE |
| K982892 | 3M Tegasorb Thin Hydrocolloid DressingKMF · Traditional | 10/26/1998SE |
| K981647 | 3M Dent II SystemEBF · Traditional | 08/09/1998SE |
| K981325 | 3M M.G. MaterialELW · Traditional | 06/11/1998SE |
| K973961 | 3M Dent System II PlusEMA · Traditional | 12/17/1997SE |
| K972962 | 3M Cdi Blood Parameter Monitoring System 500DRY · Traditional | 11/06/1997SE |
| K972355 | 3M Aurora SystemEBZ · Traditional | 08/29/1997SE |
| K971446 | 3M Universal Electrosurgical Pad SPLIT/SOLID(9130&9160)GEI · Traditional | 07/18/1997SE |
| K970500 | 3M Sustel Dental SystemEBF · Traditional | 04/30/1997SE |
| K970168 | 3M Quikplus SystemEBG · Traditional | 02/27/1997SE |
| K963766 | 3M Proplus SystemELW · Traditional | 10/31/1996SE |
| K962785 | 3M Dent SystemKLE · Traditional | 08/12/1996SE |
| K962065 | 3M Vitrebond Light Cure Glass Ionomer/BaseEMA · Traditional | 07/18/1996SE |
| K955382 | 3M Model 1860 Health Care Particulate Respirator Type N95FXX · Traditional | 05/01/1996SE |
| K955098 | 3M Mini-Driver Electric SystemHWE · Traditional | 01/22/1996SE |
| K954067 | 3M Model 8295ESD · Traditional | 09/28/1995SE |
| K953543 | 3M Model 8200P Multipro BteESD · Traditional | 08/23/1995SE |
| K951118 | 3M Maxi-Driver II Electric SystemGEY · Traditional | 07/06/1995SE |
| K943854 | 3M Model 8233 Hearing InstrumentESD · Traditional | 01/24/1995SE |
| K944981 | 3M Tempcare Light Cure Temporary SystemEBG · Traditional | 12/02/1994SE |
| K942493 | Scotchbond Multi-Purpose Plus Dental Adhesive SystemKLE · Traditional | 07/05/1994SE |
| K940707 | 3M Surgical Mask with Face SheildFXX · Traditional | 05/23/1994SE |
| K940624 | 3M Tegasorb Hydrocolloid DressingKMF · Traditional | 05/04/1994SN |
| K940558 | 3M XP-2000 X-Ray Film ProcessorIXW · Traditional | 03/22/1994SE |
| K935304 | 3M Dental Electronic Anesthesia (Dea) System 8670LWM · Traditional | 03/16/1994SE |
| K932129 | 3M Autoclave TapesJOJ · Traditional | 03/04/1994SE |
| K935085 | 3M Dental Electrononic Anesthesia (DEA0 System 8670 Additional ApplicationsLWM · Traditional | 01/26/1994SE |
| K935082 | 3M Dental Electronic Anesthesia (Dea) System 8670 ModificationLWM · Traditional | 01/26/1994SE |
| K935041 | 3M Temporary Crown & Bridge MaterialEBG · Traditional | 01/26/1994SE |
| K934746 | 3M Curing Light XL1500EBZ · Traditional | 01/06/1994SE |
| K933139 | 3M Vitremer Luting CementEMA · Traditional | 01/05/1994SE |
| K935095 | 8260 Series 3M Programmable Hearing InstrumentsESD · Traditional | 12/15/1993SE |
| K932459 | Fast Set Vinylpolysiloxane Bite Reg. MaterialELW · Traditional | 08/09/1993SE |
| K930086 | Ortholux XTEBZ · Traditional | 04/23/1993SE |
| K925032 | 3M Vitremer Tri-Cure Glass Ionomer SystemEMA · Traditional | 12/23/1992SE |
| K924812 | 3M Curing Light XL 3000EBZ · Traditional | 11/25/1992SE |
| K920268 | 3M Digital Disk Interface UnitLMD · Traditional | 05/27/1992SE |
| K920119 | 3M Dental Electronic Anesthesia SystemLWM · Traditional | 05/22/1992SE |
| K920425 | 3M Brand Restorative Z100EBF · Traditional | 03/20/1992SE |
| K920424 | Scotchbond Brand Multi-Purpose Adhesive SystemKLE · Traditional | 03/20/1992SE |
| K915265 | Cdi(Tm) H/S Cuvette, ModificationDRY · Traditional | 01/15/1992SE |
| K915255 | Cdi(Tm) 300, 400 & 100, ModificationDRY · Traditional | 01/15/1992SE |
| K912099 | 3M Fluid Control System Small Joint Cops CannulaHRX · Traditional | 12/09/1991SE |
| K912030 | Cdi(Tm) 2000 Blood Gas Monitoring Syst, ModifiedCBZ · Traditional | 10/30/1991SE |
| K913245 | Model 80 Hearing Aid Dispensing SystemESD · Traditional | 10/18/1991SE |
| K911842 | 3M Luting Cement, Paste a and BEMA · Traditional | 06/17/1991SE |
| K910110 | Triple Layer Fluid-Resistant Molded Face MaskFXX · Traditional | 03/20/1991SE |
| K910690 | 3M Model 8240 Ite Hearing AidESD · Traditional | 03/13/1991SE |
| K910182 | 3M Brand Ear Loop Face Mask, 2000FFXX · Traditional | 03/04/1991SE |
| K910763 | 3M Model 8245 Ite Hearing AidESD · Traditional | 02/28/1991SE |
| K910762 | 3M Model 8244 Ite Hearing AidESD · Traditional | 02/28/1991SE |
| K910761 | 3M Model 8243 Ite Hearing AidESD · Traditional | 02/28/1991SE |
| K910760 | 3M Model 8242 Ite Hearing AidESD · Traditional | 02/28/1991SE |
| K910759 | 3M Model 8241 Ite Hearing AidESD · Traditional | 02/28/1991SE |
| K903877 | MTS Femoral Hip SystemKWL · Traditional | 01/18/1991SE |
| K905483 | Memorymate Model 8270 Ite Hearing AidESD · Traditional | 12/28/1990SE |
| K904020 | Memorymate Hearing Aid with PMC ProgrammerESD · Traditional | 12/17/1990SE |
| K902404 | Sarns Delphin Centrifugal System W/Direction. FlowKFM · Traditional | 12/17/1990SE |
| K895713 | 3M Igg Fastlyme(Tm) TestLSR · Traditional | 12/14/1990SE |
| K900435 | Acsys Shearer Acetabular Cup ProsthesisLWJ · Traditional | 09/14/1990SE |
| K900262 | Acsys Selftap Acetabular Cup ProsthesisLWJ · Traditional | 09/14/1990SE |
| K900261 | Acsys Prefix Acetabular Cup ProsthesisJDI · Traditional | 09/14/1990SE |
| K901777 | 3M First Aid Bandage for Minor WoundsKGX · Traditional | 08/08/1990SE |
| K901845 | Tegaderm Brand Transparent Dressing Series 16XXKGX · Traditional | 07/23/1990SN |
| K902036 | Steri-Vac Gas Sterilizer Model 5XLFLF · Traditional | 07/19/1990SE |
| K902080 | Red Dot 2269 Infant Monitoring ElectrodeDRX · Traditional | 07/18/1990SE |
| K902198 | Sarns Delphin Base Adapter with BatteryKFM · Traditional | 07/13/1990SE |
| K900771 | Attest Brand Rapid Readout Biological IndicatorFRC · Traditional | 07/03/1990SE |
| K902041 | 3M Luting Cement - Paste a and Paste BEMA · Traditional | 06/27/1990SE |
| K900815 | Sarns 9000 Perfusion System W/Alert Only LevelDTW · Traditional | 05/09/1990SE |
| K901778 | 3M Heat Comfort Portable Self-Heating PadIMD · Traditional | 05/01/1990SE |
| K900640 | Modified MP-4 Cardioplegia Delivery System W/ConduDTR · Traditional | 04/20/1990SE |
| K900204 | Avi Model 840 Dual Channel Infusion PumpFRN · Traditional | 04/03/1990SE |
| K900601 | Sarns Delphin Base Adapter with Mini-BatteryKFM · Traditional | 03/28/1990SE |
| K897039 | Sarns Miniprime Cardioplegia Set W/Conducer(Tm)DTR · Traditional | 03/16/1990SE |
| K897013 | Avi Micro 210CM Infusion PumpFRN · Traditional | 03/08/1990SE |
| K896907 | 3M IV Flow RegulatorLDR · Traditional | 02/26/1990SE |
| K900244 | 3M Multi-Allergen Ige Fastscreen(Tm) S8DGC · Traditional | 02/21/1990SE |
| K900108 | 3M Multi-Aller. Ige Fastscreen S9 W1,6,9,10,11,12DGC · Traditional | 02/21/1990SE |
| K896671 | Sarns Membrane Oxygenator W/Integral Reser. #9461DTZ · Traditional | 02/14/1990SE |
| K900332 | Em 1149 Optimize Scotchplate Conduc Adhes Disp EleGEI · Traditional | 02/13/1990SE |
| K896257 | Leinbach Hip ProsthesisKWY · Traditional | 01/19/1990SE |
| K896161 | Avi Model 2012, 1.2 Micron Filter IV Administra.FPA · Traditional | 01/11/1990SE |
| K895120 | Bateman Upf II Hip Prosthesis SystemKWY · Traditional | 01/11/1990SE |
| K897145 | 3M Multi-Allergen Ige Fastscreen S7, (G3,4,5,6,8)DHB · Traditional | 01/10/1990SE |
| K896155 | Red Dot Cardiac Sensor SystemDRX · Traditional | 12/13/1989SE |
| K895632 | Sarns Membrane Oxygenator W/Integral Cadio. 16380DTZ · Traditional | 12/12/1989SE |
| K891237 | Model 600 Syringe PumpFRN · Traditional | 12/06/1989SE |
| K895393 | Sarns Ingant Membrane OxygenatorDTZ · Traditional | 12/04/1989SE |
| K893793 | Tenzcare Electrode 6862GXY · Traditional | 11/27/1989SE |
| K896266 | VS22 Hip ProsthesisKWY · Traditional | 11/22/1989SE |
| K895226 | Neer II Total Shoulder System & ProsthesisKWS · Traditional | 11/03/1989SE |
| K895134 | 3M Instant Fit Custom EarmoldESD · Traditional | 10/24/1989SE |
| K891992 | Tenzcare Stimulator 6890GZJ · Traditional | 10/12/1989SE |
| K894321 | Model 285 Infusion PumpFRN · Traditional | 10/05/1989SE |
| K894360 | Model 280 Infusion PumpFRN · Traditional | 10/04/1989SE |
| K894320 | Model 480 Infusion PumpFRN · Traditional | 10/04/1989SE |
| K893683 | Sarns Pressure Adjustable Safety SystemDTL · Traditional | 08/03/1989SE |
| K892052 | Sarns Medical CartLDQ · Traditional | 06/15/1989SE |
| K891288 | Tegasorb(Tm) Ulcer Dressing, #90-XXXFRO · Traditional | 06/09/1989SN |
| K891009 | Intravascular Administration Set Model 60040FPK · Traditional | 05/16/1989SE |
| K891005 | Intravascular Admini. Set Models 60030 & 60050FPK · Traditional | 05/11/1989SE |
| K885031 | Low Adsorption Administration SetFPA · Traditional | 05/05/1989SE |
| K890808 | Sarns Membrane Oxygenator W/Integral Cardio ReservDTZ · Traditional | 05/01/1989SE |
| K890354 | Tegapore Wound Contact Material, Product #563XNAD · Traditional | 04/27/1989SN |
| K890771 | Aseptex 1812 Sub-Micron Molded Surgical MaskFXX · Traditional | 03/14/1989SE |
| K890024 | Sarns Vent CatheterDWF · Traditional | 03/02/1989SE |
| K890501 | Second AssistantFWZ · Traditional | 02/10/1989SE |
| K885222 | Precise Ila and Ilan Surgical StaplesGDW · Traditional | 02/03/1989SE |
| K885030 | Standard Administration SetsFPA · Traditional | 01/24/1989SE |
| K883544 | Lyme Fast TestLSR · Traditional | 01/13/1989SE |
| K885065 | Ige Fastscreen S6 (F1, F2, F4, F13, F14)DHB · Traditional | 01/04/1989SE |
| K883371 | Multi-Allergen Ige Fastscreen V (T1,T3,T5,T7,T10)DHB · Traditional | 10/27/1988SE |
| K882821 | Vitrabond Light Cure Glass Ionomer LinerEKJ · Traditional | 09/15/1988SE |
| K883273 | Dhbti-Allergen Ige Fastscreen IV (G1,G5,G12,G13)DHB · Traditional | 09/07/1988SE |
| K882690 | Imprint Vinyl Polysiloxane Impression MaterialELW · Traditional | 08/11/1988SE |
| K881703 | 3M Carpal TunnelHRX · Traditional | 07/25/1988SE |
| K881988 | 3M Wound Contact Material, Product #563XNAD · Traditional | 06/27/1988SE |
| K881618 | Aseptex 1809 Fluid-Resistant Molded Surgical MaskFXX · Traditional | 05/09/1988SE |
| K872298 | Tegasorb Ulcer Dressing #90-XXXFRO · Traditional | 04/01/1988SN |
| K880565 | 3M Trimatic M Modular System and AccessoriesIXW · Traditional | 03/21/1988SE |
| K880564 | 3M XP 505 X-Ray Film ProcessorIXW · Traditional | 03/21/1988SE |
| K880563 | 3M XP515 X-Ray Film ProcessorIXW · Traditional | 03/21/1988SE |
| K880082 | Memorymate Hearing Aid Model 8200ESD · Traditional | 03/09/1988SE |
| K880001 | Multi-Allergen Ige Fast Screen III D1,E1,G6,M2,T3DHB · Traditional | 02/25/1988SE |
| K880002 | Multi-Allergen Ige Fast Screen (Molds)DHB · Traditional | 02/17/1988SE |
| K874446 | Multi-Allergen Ige Fast Screen (Environmental)DHB · Traditional | 12/30/1987SE |
| K874086 | 3M Brand Laser Protection Surgical Drapes, 88XXKKX · Traditional | 12/17/1987SE |
| K873998 | Total Ige Fast (TM) Test PackageDHB · Traditional | 11/04/1987SE |
| K872444 | Silux Plus Light Cured Restorative MaterialEBF · Traditional | 09/11/1987SE |
| K872279 | Scotchbond 2 Adhesive W/Scotchprep Dentin PrimerEBF · Traditional | 07/02/1987SE |
| K870985 | 3M Instant Fit Custom EarmoldESD · Traditional | 03/30/1987SE |
| K870151 | Total/Ige Theophylline Control SeraJJX · Traditional | 03/12/1987SE |
| K870543 | Steri-Tractor Wound RetractorGAD · Traditional | 02/24/1987SE |
| K870153 | Allergen Specific IGG4 Control SeraDHB · Traditional | 02/12/1987SE |
| K864104 | Additonal Allergens for Ige Fast (TM) TestDHB · Traditional | 02/12/1987SE |
| K870152 | Allergen Specific ControlsDHB · Traditional | 02/06/1987SE |
| K864973 | Tenzcare(Tm) Snap Electrode 6867GXY · Traditional | 01/20/1987SE |
| K863967 | Specific Ige Fast(Tm) Test IIDHB · Traditional | 12/22/1986SE |
| K864270 | 3M Glass Ionomer LinerEMA · Traditional | 12/16/1986SE |
| K861985 | 3M Brand Microvascular Anastomotic Coupler (27XX)MVR · Traditional | 12/04/1986SE |
| K863794 | 3M IGG4 Fast Test PackageDHB · Traditional | 12/03/1986SE |
| K863475 | Theofast(Tm) Test PackageLER · Traditional | 11/05/1986SE |
| K863307 | Tenzcare Snap Electrode, No. 6865GXY · Traditional | 09/23/1986SE |
| K863129 | 3M Corneal System (Corneal Preservation Medium)LYX · Traditional | 09/17/1986SE |
| K862590 | 3M Esthetic Design System (Tints & Masking Agents)EBD · Traditional | 07/22/1986SE |
| K861899 | Scotchbond Light Cured Dental Adhesive W/FluorideEBF · Traditional | 06/25/1986SE |
| K861740 | P-50 Light Cured Resin Bonded CeramicEBF · Traditional | 05/21/1986SE |
| K860600 | Single/Multiple Component Metallic Bone FixationHRS · Traditional | 03/13/1986SE |
| K855216 | 3M Arthroscopic Surgical SystemHWE · Traditional | 03/04/1986SE |
| K855043 | 3M Dry Silver ImagerLMC · Traditional | 01/10/1986SE |
| K853698 | Scotchprime Ceramic PrimerEIH · Traditional | 11/14/1985SE |
| K852750 | Tegaderm Plus Transparent Dressing #952XFRO · Traditional | 09/19/1985SESD |
| K851982 | Kitecko Ultrasound Standoff PadIYO · Traditional | 08/14/1985SE |
| K852567 | 3M Fukuda Type Ring RetractorGAD · Traditional | 07/09/1985SE |
| K851046 | Myocare Plus Dual Channel StimulatorIPF · Traditional | 07/01/1985SN |
| K851459 | Visilux 2 Visible Light Curing UnitEBF · Traditional | 05/21/1985SE |
| K844211 | Concise Light Cured White SealantEBC · Traditional | 01/07/1985SE |
| K843502 | 3M Laser ImagerLMC · Traditional | 11/29/1984SE |
| K840566 | Bone Stapling Fixation SysJDR · Traditional | 11/23/1984SE |
| K842382 | 3M Rapidstat Ligating Clip SysFZP · Traditional | 08/10/1984SE |
| K842523 | Bird Heated Humidifier 3201BTT · Traditional | 07/11/1984SE |
| K841550 | Scotchbond Light Cured Dental AdhesEBF · Traditional | 06/22/1984SE |
| K833797 | Light Cured Resin Bonded CeramicEBF · Traditional | 04/25/1984SE |
| K833364 | 3M Scotchplate II Dispersive ElectrodeGEI · Traditional | 11/29/1983SE |
| K832318 | Isolation Bag 3MKGY · Traditional | 10/31/1983SE |
| K832834 | Concise 2 Small Particle Light CurvedEBD · Traditional | 09/29/1983SE |
| K830361 | MMS Acetabular CupsJDI · Traditional | 09/29/1983SE |
| K831233 | Glenoid Resurfacing COMPONENT-3M-10816KWT · Traditional | 06/03/1983SE |
| K831234 | Glenoid Resurface Component PMN 3MKWT · Traditional | 06/02/1983SE |
| K831367 | PMN Volz CurettesFZS · Traditional | 05/25/1983SE |
| K831104 | Tenzcare Muscle Stimulation ElectrodesGXY · Traditional | 05/09/1983SE |
| K830360 | 3M Osteotomy GuideHWT · Traditional | 03/01/1983SE |
| K813265 | 3M Steri-Strip Antimicrobial Skin ClosKGX · Traditional | 02/09/1983SE |
| K823689 | 3M Scotchplate 51148 Small ConductiveGEI · Traditional | 01/12/1983SE |
| K823888 | 3M Frascia Stapling SystemGEF · Traditional | 01/09/1983SE |
| K822714 | Conclude Composite Luting CementEBD · Traditional | 09/28/1982SE |
| K821909 | Littman Tunable Stethoscope 2136LDE · Traditional | 07/14/1982SE |
| K821438 | Red Dot Monitoring Electrodes #2260/65DRX · Traditional | 05/25/1982SE |
| K820582 | 3M Thinsulate Disposable Hospital BedKME · Traditional | 03/18/1982SE |
| K820299 | Prompt Inoculation SystemLIE · Traditional | 03/15/1982SE |
| K820132 | Babybird 2 VentilatorCBK · Traditional | 01/28/1982SE |
| K820131 | 3M Volume Ventiator CircuitBZO · Traditional | 01/28/1982SE |
| K812678 | Tegaderm Transparent DressingFRO · Traditional | 01/25/1982SE |
| K813180 | Scotchbond Dental AdhesiveKLE · Traditional | 01/12/1982SE |
| K812867 | Steri-Vac #400C Gas SterilizerFLF · Traditional | 11/02/1981SE |
| K801550 | 3M Germicidal Surgical Incise DrapeKKX · Traditional | 09/17/1981SE |
| K812442 | 3M Infusion SystemFRN · Traditional | 09/16/1981SE |
| K812140 | Bird Mean Airway Pressure MonitorCAP · Traditional | 08/20/1981SE |
| K811670 | Steri-Lok Dual Purpose PACKAGING/8400FRG · Traditional | 07/10/1981SE |
| K811291 | Tegaderm Transparent DressingKGX · Traditional | 06/02/1981SE |
| K810595 | Silux Restorative Material & Enamel BondEBF · Traditional | 03/24/1981SE |
| K810580 | Scotch Brand Adhesive TapeKGX · Traditional | 03/20/1981SE |
| K801748 | 3M I-125 Seeds in Absorbable CarrierKXK · Traditional | 12/18/1980SE |
| K802751 | P-10 Posterior Filling MaterialEBH · Traditional | 11/12/1980SE |
PMA approvals
- P850069 Kennedy Lad(Tm) Ligament Augmentation Device · 05/07/1987 · 11 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2231-2025 Class II | 3M Ranger Irrigation Fluid Warming Set, REF 24750Notice was issued to clarify flow rates related to the inlet fluid temperature. | 04/22/2025Open, Classified |
| Z-2483-2025 Class I | 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet… | 04/10/2025Open, Classified |