Intermedics, Inc.
Medical device manufacturer in Angleton, TX.
211510(k) clearances
0PMA approvals
0recalls
Device types
- DTB Permanent Pacemaker Electrode 105
- DXY Implantable Pacemaker Pulse-Generator 52
- DTD Pacemaker Lead Adaptor 14
- FRN Pump, Infusion 7
- DXH Transmitters And Receivers, Electrocardiogra… 5
- KRG Programmer, Pacemaker 4
- GZJ Stimulator, Nerve, Transcutaneous, For Pain… 3
- GEI Electrosurgical, Cutting & Coagulation &… 2
- DTE Pulse-Generator, Pacemaker, External 2
- DBT Factor Xiii A, S, Antigen, Antiserum, Control 1
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- DSA Cable, Transducer And Electrode, Patient… 1
- KFJ Materials, Repair Or Replacement, Pacemaker 1
- DYB Introducer, Catheter 1
- JOS Electrode, Electrosurgical 1
- DRG Transmitters And Receivers, Physiological… 1
- HLM Instrument, Measuring, Lens, Ac-Powered 1
- GDX Scalpel, One-Piece 1
- HPS Unit, Cryophthalmic 1
- BXN Stimulator, Nerve, Battery-Powered 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | 12/16/1996PT |
| K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional | 11/04/1996ST |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | 08/21/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | 02/27/1996ST |
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | 03/15/1995SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | 01/22/1993SESP |
| K920530 | Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional | 03/17/1992SE |
| K912235 | Models 432-03 & 433-03 Implant Endocard Pac LeadDTB · Traditional | 09/18/1991SE |
| K911122 | 8MM Quantum Pulse/Suprima II Pulse GeneratorsDXY · Traditional | 05/16/1991SE |
| K903948 | Intermedics Model 431-11 Implant Endocard Pac LeadDTB · Traditional | 04/22/1991SE |
| K902672 | Intermedics 430-07 Bipol Implant Endocard Pac LeadDTB · Traditional | 03/01/1991SE |
| K894718 | Adaptaid(Tm) Adapter Sleeve Model 366-33DTD · Traditional | 09/05/1989SE |
| K890412 | Models 430-07 & 431-07 Implantable Pacing LeadsDTB · Traditional | 03/28/1989SE |
| K890411 | Models 432-03 & 433-03 Implantable Pacing LeadsDTB · Traditional | 03/28/1989SE |
| K883602 | Biopore VS.1 Endocardial Inter Implant Pacing LeadDTB · Traditional | 09/06/1988SE |
| K875178 | Model 435-04 Cardifix Side Hook Implant. Pace LeadDTB · Traditional | 05/25/1988SE |
| K875100 | Model 438-03 Cardifix Side Hook Implant. Pace LeadDTB · Traditional | 05/24/1988SE |
| K872126 | Model 438-02 Cardifix Side Hook Implant. Pace LeadDTB · Traditional | 03/22/1988SE |
| K880551 | Model 439-07 and 439-09 Lifeline Myocardial LeadDTB · Traditional | 03/07/1988SE |
| K874531 | Polyflex(R) Epicardial 439-04 Implant Pacing LeadDTB · Traditional | 01/07/1988SE |
| K874930 | Model 366-12 Adaptaid(Tm) Step-Down AdapterDTB · Traditional | 01/06/1988SE |
| K873921 | Model 366-30 Adaptaid(Tm) Adapter SleeveDTB · Traditional | 12/03/1987SE |
| K874394 | Quantum(R) Models 253-19V & 254-20V Pulse Genera.DXY · Traditional | 11/23/1987SE |
| K873528 | Modified Models 253-19 & 254-20 Quantum GeneratorsDXY · Traditional | 10/09/1987SE |
| K872230 | Model 366-29 Adaptaid(Tm) Adapter SleeveDBT · Traditional | 09/15/1987SE |
| K871580 | Implantable Pacing Lead Models 487-06 to 430-01DTB · Traditional | 05/22/1987SE |
| K871625 | Model 366-12 Adaptaid (TM) Step-Down AdapterDTB · Traditional | 05/21/1987SE |
| K870357 | Electrode, Pacemaker, Permanent & TemporaryDTB · Traditional | 05/21/1987SE |
| K870948 | Model 435-03 Side Hook Implantable Pacing LeadDTB · Traditional | 04/10/1987SE |
| K864326 | Model 366-13 Adaptaid Step Down AdapterDTB · Traditional | 01/16/1987SE |
| K864738 | Model 366-14 Intermedics Lead Connector CapDTB · Traditional | 01/06/1987SE |
| K862051 | Model 436-01 Biopore Implantable Pacing LeadDTB · Traditional | 01/06/1987SE |
| K864564 | Model 486-05 Polyflex(R) Implantable Pacing LeadDTB · Traditional | 12/05/1986SE |
| K864428 | Model 366-23 Adaptaid(Tm) Step-Down AdapterDTB · Traditional | 12/05/1986SE |
| K864287 | Model 430-05 Polyflex Implantable Pacing LeadDTB · Traditional | 11/20/1986SE |
| K864002 | Model 431-06 Polyflex Implantable Pacing LeadDTB · Traditional | 11/20/1986SE |
| K864048 | Model 366-27 Adaptaid(Tm) Step-Down AdapterDTB · Traditional | 11/03/1986SE |
| K864047 | Model 366-28 Adaptaid(Tm) Step-Down AdapterDTB · Traditional | 11/03/1986SE |
| K863781 | Model 493-08 Polyflex Endocardial LeadDTB · Traditional | 11/03/1986SE |
| K863418 | Model 352-01 Silicone Rubber Isolation SleeveDXY · Traditional | 09/24/1986SE |
| K862054 | Model 430-01 Biopore Implantable Pacing LeadDTB · Traditional | 09/19/1986SE |
| K862053 | Model 432-01 Biopore Implantable Pacing LeadDTB · Traditional | 09/19/1986SE |
| K862259 | Model 433-01 Biopore Implantable Pacing LeadDTB · Traditional | 07/10/1986SE |
| K862258 | Model 437-01 Biopore Implantable Pacing LeadDTB · Traditional | 07/10/1986SE |
| K862257 | Model 431-02 Biopore Implantable Pacing LeadDTB · Traditional | 07/10/1986SE |
| K862052 | Model 438-01 Cardifix Implantable Pacing LeadDTB · Traditional | 07/03/1986SE |
| K862276 | Model 435-02 Cardifix Implantable Pacing LeadDTB · Traditional | 07/02/1986SE |
| K860548 | Model 492-02 Endocardial Pacing LeadDTB · Traditional | 06/13/1986SE |
| K860547 | Model 486-02 Endocardial Pacing LeadDTB · Traditional | 06/13/1986SE |
| K861176 | Model 366-20 Adaptaid Step-Down AdapterDTB · Traditional | 04/29/1986SE |
| K861110 | Model 366-10 Adaptaid Step-Down AdapterDTB · Traditional | 04/23/1986SE |
| K860986 | Model 366-09 Adaptaid Adapter SleeveDTB · Traditional | 03/31/1986SE |
| K860985 | Model 366-19 Adaptaid Adapter SleeveDTB · Traditional | 03/31/1986SE |
| K860832 | Model 366-08 Adaptaid Connector AdapterDTD · Traditional | 03/31/1986SE |
| K854918 | Model 431-01 Biopore Implantable Pacing LeadDTB · Traditional | 03/11/1986SE |
| K854917 | Model 435-01 Cardifix Implantable Pacing LeadDTB · Traditional | 03/11/1986SE |
| K854069 | Polyflex 483-09 Endocardial Implantable PacingleadDTB · Traditional | 12/09/1985SE |
| K854071 | Polyflex 493-07 Endocardial Implantable Pac-LeadDTB · Traditional | 12/04/1985SE |
| K853521 | Polyflex Implantable Pacing LEAD-476-07DTB · Traditional | 12/04/1985SE |
| K853517 | Lifeline Endocardial Unipolar Lead 483-08DTB · Traditional | 12/04/1985SE |
| K852340 | Suprima Model 254-24DXY · Traditional | 11/08/1985SE |
| K852339 | Suprima Model 254-22DXY · Traditional | 11/08/1985SE |
| K853518 | Lifeline Endocardial Bipolar Lead 476-06DTB · Traditional | 11/05/1985SE |
| K853519 | Lifeline Endocardial Bipolar Lead 484-03DTB · Traditional | 10/24/1985SE |
| K853410 | Model 492-03 Polyflex Implantable Pacing LeadDTR · Traditional | 10/11/1985SE |
| K853520 | Lifeline Endocardial Unipolar 487-06 Tle LeadDTB · Traditional | 10/08/1985SE |
| K853411 | Model 486-03 Poly Flex Implantable Pacing LeadDTB · Traditional | 10/01/1985SE |
| K844814 | Biopore 493-05 Endocardial Implantable Pacing LeadDTD · Traditional | 08/29/1985SE |
| K853034 | #335-01 Silic Rub Isola Sleeve for Int #281-03 SizDXY · Traditional | 07/25/1985SE |
| K852431 | Suprima II Model 254-26DXY · Traditional | 07/19/1985SE |
| K852432 | Suprima II Model 254-28DXY · Traditional | 07/17/1985SE |
| K852430 | Suprima II Model 253-23DXY · Traditional | 07/17/1985SE |
| K851458 | Model 493-04 Polyflex R Implantable Pacing LeadDTD · Traditional | 07/11/1985SE |
| K851457 | Model 483-06 Polyflex Implantable Pacing LeadDTD · Traditional | 07/11/1985SE |
| K851063 | Tensmed IIGZJ · Traditional | 06/04/1985SE |
| K820267 | Intermedics Polyflex Pacing Lead #480-01DTB · Traditional | 04/03/1985SE |
| K813136 | Model 492-01 Pacemaker LeadDTB · Traditional | 04/03/1985SE |
| K813135 | Model 486-01 Pacemaker LeadDTB · Traditional | 04/03/1985SE |
| K802294 | Poly Flex Implantable Pacing LeadDTB · Traditional | 04/03/1985SE |
| K844272 | Model 473-03 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844271 | Model 479-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844270 | Model 480-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844269 | Model 483-02 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844268 | Model 483-03 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844267 | Model 483-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844266 | Model 492-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844265 | Model 495-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844264 | Model 493-03 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844263 | Model 493-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844262 | Model 483-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844261 | Model 490-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844260 | Model 476-03 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844259 | Model 486-01 Pacing LeadDTB · Traditional | 03/28/1985SE |
| K844793 | Suprima 253-21 Implantable Pulse GeneratorDXY · Traditional | 02/08/1985SE |
| K844279 | Interceptor, 662-01GZJ · Traditional | 01/24/1985SE |
| K843331 | Intermedics/Graseby Dynamics MS 36FRN · Traditional | 11/15/1984SE |
| K843548 | Intermedics Syringe Pump 710-02FRN · Traditional | 10/31/1984SE |
| K843394 | Lifeline Tle 484-02DTB · Traditional | 09/24/1984SE |
| K843393 | Lifeline Tle 476-04DTB · Traditional | 09/24/1984SE |
| K841647 | Neuromedics Ultrastim 650-01IPF · Traditional | 07/03/1984SE |
| K841404 | Prima 236-02 Nonprogrammable CardiacDXY · Traditional | 05/30/1984SE |
| K841075 | Carciac Pulse Generator 254-20DXY · Traditional | 05/16/1984SE |
| K841074 | Cardiac Pulse Generator 254-18DXY · Traditional | 05/16/1984SE |
| K841073 | Quantum, Unipolar, Multi-ProgrammableDXY · Traditional | 05/16/1984SE |
| K833655 | Gillette Sabre SyringeFRN · Traditional | 12/29/1983SE |
| K834096 | Implantable Pulse GeneratorDXY · Traditional | 12/16/1983SE |
| K832914 | Prima-Unipolar Cardiac Pulse GeneratDXY · Traditional | 11/14/1983SE |
| K833199 | Silicone Rubber Isolation Sleeve 350-01DXY · Traditional | 10/28/1983SE |
| K833198 | Silicone Rubber Isolation Sleeve 351-01DXY · Traditional | 10/27/1983SE |
| K831633 | Quantum Bipolar Cardiac Pulse GeneratorDXY · Traditional | 10/12/1983SE |
| K832410 | Graseby Dynamics MS302 Syringe DriverFRN · Traditional | 09/12/1983SE |
| K832409 | Lifeline Pacing Leads #471-07 &09DTB · Traditional | 08/12/1983SE |
| K830782 | Lifeline Endocardial Pacing Lead #479-05DTB · Traditional | 04/18/1983SE |
| K830809 | Grase by Dynamics MS 27 Syringe DriverFRN · Traditional | 04/14/1983SE |
| K823863 | Cyberlith Ix Quantum-Unipolar CardiacDXY · Traditional | 03/10/1983SE |
| K830423 | Syringe Driver MS-16FRN · Traditional | 03/07/1983SE |
| K830463 | Lifeline Unipolar J-Lead #483-05DTB · Traditional | 02/28/1983SE |
| K830151 | External Infusion PumpFRN · Traditional | 02/18/1983SE |
| K823508 | Lifeline -Unipolar Lead #487-05DTB · Traditional | 01/14/1983SE |
| K823290 | Neuromedics Pacetron Heart Rate MonitorDRT · Traditional | 12/30/1982SE |
| K823678 | Telemetry Decoder #540-02DXY · Traditional | 12/22/1982SE |
| K822704 | Model 366-07 Adapt Aid Lead AdapterDTD · Traditional | 11/24/1982SE |
| K822600 | Neuromedics Orions #660-01GZJ · Traditional | 09/24/1982SE |
| K821726 | Model 535-02 Trace-A-Pace TransmitterDXH · Traditional | 07/08/1982SE |
| K820487 | Implantible Suture SleeveDTB · Traditional | 04/16/1982SE |
| K820853 | Quantum Models 253-09, 254-09 254-10DXY · Traditional | 04/09/1982SE |
| K820268 | Adaptaid Temp. Pacing Ext. Lead #366-02DSA · Traditional | 03/26/1982SE |
| K813518 | Implant Aid Splicing Crimp & SleeveKFJ · Traditional | 01/12/1982SE |
| K813028 | Poly-Flex Pacing LeadsDTB · Traditional | 12/10/1981SE |
| K812991 | Intermedics Polyflex-Model 483-04 LeadDTB · Traditional | 11/16/1981SE |
| K812990 | Intermedics Polyflex-Model 483-03 LeadDTB · Traditional | 11/16/1981SE |
| K812989 | Intermedics Polyflex-Model 493-03 LeadDTB · Traditional | 11/16/1981SE |
| K812755 | Model 535-03 Trace a PaceDXH · Traditional | 11/16/1981SE |
| K812756 | Adaptaid #365-38DTD · Traditional | 10/29/1981SE |
| K812813 | Intermedics Programmer, Model 522-03KRG · Traditional | 10/27/1981SE |
| K812812 | Intermedics Adaptaid Step-Down AdapterDTD · Traditional | 10/27/1981SE |
| K812502 | Implantaid Lead Introducer #319-10 & 12DYB · Traditional | 10/13/1981SE |
| K812245 | Intermedics Poly Flex Endocardial AtrialDTB · Traditional | 10/06/1981SE |
| K812221 | Intermedics Poly Flex Epicardial SutureDTB · Traditional | 10/06/1981SE |
| K811464 | Model 535-01 Trace-A-Pace Ekg/TelemetryDXH · Traditional | 09/23/1981SE |
| K801339 | Telemetry DecoderDXY · Traditional | 09/23/1981SE |
| K801337 | Cyberlith Ix Implantable Pulse GeneratorDXY · Traditional | 09/23/1981SE |
| K811920 | Adaptaid Lead Adapter, #365-17DTD · Traditional | 08/13/1981SE |
| K811938 | Adaptaid Lead Adapter #365-25DTD · Traditional | 08/07/1981SE |
| K811221 | Intermedics Cyberlith Bipolar CardiacDXY · Traditional | 05/27/1981SE |
| K811106 | Intermedics Poly Flex Endocardial PacingDTB · Traditional | 05/27/1981SE |
| K811066 | Model 230-06 Cyberlith TM I Bipolar inDXY · Traditional | 05/01/1981SE |
| K810800 | Model 230-05 Cyberlith I Bipol. Pulse G.DXY · Traditional | 05/01/1981SE |
| K810752 | Thinlith III Unipolar Cardiac Pulse Gen.DXY · Traditional | 05/01/1981SE |
| K810901 | Insulative Coating for Card. Pulse GenDXY · Traditional | 04/14/1981SE |
| K810628 | Electrosurgical Cutting & CoagulationJOS · Traditional | 04/03/1981SE |
| K810385 | Cyberlith I Pulse Generator Model 253-04DXY · Traditional | 04/01/1981SE |
| K810383 | Intermedics Cyberlith I Biopolar CardiDXY · Traditional | 04/01/1981SE |
| K810386 | Thinlith II Pulse Gneerator Model 227-05DXY · Traditional | 03/13/1981SE |
| K810245 | Implantable Pacemaker Lead AdapterDTD · Traditional | 03/04/1981SE |
| K810384 | Intermedics Cyberlith I Unipolar Cardiac · Traditional | 02/13/1981SESP |
| K802357 | Telemetry Pacemaker MonitorDRG · Traditional | 02/12/1981SE |
| K802295 | Poly Flex Implantable Pacing LeadDTB · Traditional | 02/09/1981SE |
| K801338 | Cyberlith ProgrammerDXY · Traditional | 01/07/1981SE |
| K801172 | Intermedics' Lifeline Tle EndocardialDTB · Traditional | 12/01/1980SE |
| K802293 | Polyflex Implantable Pacing LeadDTB · Traditional | 10/31/1980SE |
| K801055 | Compupace, 524-01 Pacer System ComputerDTE · Traditional | 10/31/1980SE |
| K802040 | Battery for #229-01 Pulse GeneratorDXY · Traditional | 09/09/1980SE |
| K801450 | Intermedics Thin Lith IV Series UnipolarDXY · Traditional | 08/14/1980SE |
| K801039 | Adaptaid Helical Coil Adapter 365-14DTD · Traditional | 07/21/1980SE |
| K801038 | Adaptaid Elema Lead Adapter Kit 365-17DTD · Traditional | 07/08/1980SE |
| K801040 | GE Lead Adapter, Model 345-01DTD · Traditional | 06/30/1980SE |
| K792301 | Lifeline Tle J-Shaped Atrial EndocardialDTB · Traditional | 06/04/1980SE |
| K792300 | Lifeline Tle (Traebecular Lodging ElecDTB · Traditional | 06/04/1980SE |
| K800895 | Model 253-11 Cyberlith Pulse GeneratorDXY · Traditional | 04/24/1980SE |
| K800644 | Cyberlith Implantable Pulse Gen. #253-02DXY · Traditional | 04/16/1980SE |
| K800645 | Cyberlith Implantable Pulse Gen. #253-04DXY · Traditional | 04/08/1980SE |
| K792604 | Lifeline Tle Endocardial Pacing Lead,DTB · Traditional | 12/31/1979SE |
| K792168 | Lifeline - Endocardial Pacing LeadDTB · Traditional | 11/13/1979SE |
| K791521 | Veri-Vu LensometerHLM · Traditional | 10/30/1979SE |
| K791568 | Implantable Pulse Generator PacemakersDXY · Traditional | 09/19/1979SE |
| K791379 | Model 228-02 Thinlith II Pacemaker, BipoDXY · Traditional | 09/12/1979SE |
| K791378 | Model 482-01 Bipolar Coaxial Pacing LeadDTB · Traditional | 09/12/1979SE |
| K791377 | Model 484-01 Bipolar Coaxial Pacing LeadDTB · Traditional | 09/12/1979SE |
| K791417 | Implantable Pulse Generator PacemakerDXY · Traditional | 09/04/1979SE |
| K791362 | Electrosurgical Cut and Coagu AccessoryGEI · Traditional | 09/04/1979SE |
| K790220 | Pacemaker ProgrammerKRG · Traditional | 07/31/1979SE |
| K790548 | Endocardial Pacing Lead, Model 476-01DTB · Traditional | 06/01/1979SE |
| K790259 | Sterile Disposable KnifeGDX · Traditional | 02/13/1979SE |
| K790102 | Model 556-01 CryoextractorHPS · Traditional | 02/12/1979SE |
| K790123 | Stimulator, Battery PoweredBXN · Traditional | 02/06/1979SE |
| K781570 | Sutureless Muocardine Pacing Leads 471DTB · Traditional | 02/01/1979SE |
| K781525 | Endocaridal Pacing Lead Unipolar 477DTB · Traditional | 02/01/1979SE |
| K781499 | Lifeline Pacing Lead Model 467-01DTB · Traditional | 02/01/1979SE |
| K781498 | Lifeline Bipolar Pacing Lead Mod. 466-01DTB · Traditional | 02/01/1979SE |
| K781497 | Lifeline Pacing Lead Model 465-01DTB · Traditional | 02/01/1979SE |
| K790221 | Pulse Generator, Cyberlith Implantable · Traditional | 01/30/1979SESP |
| K790101 | Isolation Sleeve, Model 346-01DXY · Traditional | 01/24/1979SE |
| K790100 | Isolation Sleeve, Model 348-01DXY · Traditional | 01/24/1979SE |
| K790099 | Isolation Sleeve, Model 347-01DXY · Traditional | 01/24/1979SE |
| K790098 | Isolation Sleeve, Model 349-01DXY · Traditional | 01/24/1979SE |
| K781327 | Pulse Generator, Model 240, ExternalDTE · Traditional | 12/11/1978SE |
| K781738 | Pacemaker, Model 229-01DXY · Traditional | 12/07/1978SE |
| K781569 | Nerve Locater/StimulatorETN · Traditional | 12/07/1978SE |
| K781568 | Pacemaker, Model 251-01 · Traditional | 10/18/1978SE |
| K772226 | Pacemaker, Model 225 & 227DXY · Traditional | 09/27/1978SE |
| K780175 | Rate Programmer Model 520KRG · Traditional | 04/21/1978SE |
| K780437 | Pacemaker, Model 252, C-MosDXY · Traditional | 04/05/1978SE |
| K772350 | Patient Alert Model 555DXH · Traditional | 03/09/1978SE |
| K772186 | Electrocardiograph Transmitter, 536DXH · Traditional | 02/02/1978SE |
| K772199 | Cauteries, Hot Wire, Disp.GEI · Traditional | 12/13/1977SE |
| K772057 | Bipolar Pacemaker Model 224DXY · Traditional | 11/03/1977SE |
| K771626 | Pacemaker Model 251DXY · Traditional | 09/12/1977SE |