Micromedics, Inc.
Medical device manufacturer in Minneapolis, MN.
29510(k) clearances
0PMA approvals
5recalls
Device types
- GCJ Laparoscope, General & Plastic Surgery 5
- KYZ Syringe, Irrigating (Non Dental) 4
- FMF Syringe, Piston 4
- ETD Tube, Tympanostomy 2
- KAM Cannula, Sinus 2
- KDC Instrument, Surgical, Disposable 1
- ESX Tack, Sacculotomy (Cody Tack) 1
- ETF Unit, Examining/Treatment, Ent 1
- HBB Motor, Drill, Pneumatic 1
- EQJ Bur, Ear, Nose And Throat 1
- CAF Nebulizer (Direct Patient Interface) 1
- LFB Button, Nasal Septal 1
- ETA Replacement, Ossicular Prosthesis, Total 1
- ETB Prosthesis, Partial Ossicular Replacement 1
- KCT Sterilization Wrap Containers, Trays… 1
- MJV Device, Inflation, Middle Ear 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K241739 | Endoscopic Applicator, 41 cmGCJ · Special | 07/15/2024SE |
| K123847 | Malleable Tip Endoscopic ApplicatorGCJ · Special | 01/08/2013SE |
| K122526 | 360 Gas Assisted Endoscopic ApplicatorGCJ · Special | 11/16/2012SE |
| K120608 | Endoscopic ApplicatorGCJ · Traditional | 03/15/2012SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | 03/15/2011SE |
| K100754 | Graft Delivery System Model SA-6115FMF · Traditional | 06/09/2010SE |
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000MJV · Traditional | 03/14/2008SE |
| K061092 | Baxter Duplospray Mis ApplicatorFMF · Traditional | 09/13/2006SE |
| K051157 | Instru-Safe Instrument Protection SystemsKCT · Traditional | 09/01/2005SE |
| K050340 | Micromedics Sphenoid Sinus StentKAM · Traditional | 04/27/2005SE |
| K042834 | Micromedics Fibrijet Air Assisted Endoscopic ApplicatorGCJ · Traditional | 02/11/2005SE |
| K033589 | Baxter Duplotip Surgical Sealant ApplicatorFMF · Traditional | 10/04/2004SE |
| K012868 | Micromedics Fibrijet Aerosol ApplicatorFMF · Traditional | 10/29/2001SE |
| K993234 | Micromedics S&T Partial Ossicular Replacement ProsthesisETB · Traditional | 11/10/1999SE |
| K991670 | Silverstein MicrowickETD · Traditional | 08/26/1999SE |
| K992138 | Micromedics S&T Total Ossicular Replacement Prosthesis and AccessoriesETA · Traditional | 08/09/1999SE |
| K982667 | Micromedics Nasal Septal ButtonLFB · Traditional | 11/24/1998SE |
| K940371 | Surgical Sealant Applicator Tip Endoscopic TipKYZ · Traditional | 04/06/1994SE |
| K912418 | Shikani Middle Meatal Antrostomy Vent TubeKAM · Traditional | 12/20/1991SE |
| K911785 | Rhino-GuardCAF · Traditional | 10/07/1991SE |
| K895738 | Micromedics Ear, Nose and Throat BursEQJ · Traditional | 12/19/1989SE |
| K895739 | Micromedics Surgical Drill SystemHBB · Traditional | 10/13/1989SE |
| K883338 | Surgical Sealant ApplicatorKYZ · Traditional | 08/23/1988SE |
| K881020 | Surgical Sealant Dispenser (SSD)KYZ · Traditional | 03/25/1988SE |
| K860940 | Micromedics Sterile, Disposable ENT Exam KitETF · Traditional | 05/02/1986SE |
| K842212 | Micromedics Surgical Instruments · Traditional | 10/01/1984SE |
| K832068 | Cody Sacculotomy TackESX · Traditional | 10/19/1983SE |
| K832680 | Micro-Edge Disposable BladesKDC · Traditional | 10/14/1983SE |
| K830228 | Otological Ventilation Tubes-VariousETD · Traditional | 03/07/1983SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1817-2017 Class II | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445.…The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the… | 10/20/2016Terminated |
| Z-0348-2011 | VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… | 03/15/2010Terminated |
| Z-0347-2011 | SP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… | 03/15/2010Terminated |
| Z-0346-2011 | ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… | 03/15/2010Terminated |
| Z-0345-2011 | AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… | 03/15/2010Terminated |