Company ยท US
Micromedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2024. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | 6 |
| GCJ | Laparoscope, General & Plastic Surgery | 5 |
| FMF | Syringe, Piston | 4 |
| ETD | Tube, Tympanostomy | 3 |
| KAM | Cannula, Sinus | 2 |
| LFB | Button, Nasal Septal | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| EQJ | Bur, Ear, Nose And Throat | 1 |
| ESX | Tack, Sacculotomy (Cody Tack) | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 |
| ETB | Prosthesis, Partial Ossicular Replacement | 1 |
| ETF | Unit, Examining/Treatment, Ent | 1 |
| HBB | Motor, Drill, Pneumatic | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| KGZ | Accessories, Catheter | 1 |
| MJV | Device, Inflation, Middle Ear | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2024 | K241739 | Endoscopic Applicator, 41 cm Micromedics, Inc. | GCJ |
| Jan 8, 2013 | K123847 | MALLEABLE TIP ENDOSCOPIC APPLICATOR Micromedics, Inc. | GCJ |
| Nov 16, 2012 | K122526 | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR Micromedics, Inc. | GCJ |
| Mar 15, 2012 | K120608 | ENDOSCOPIC APPLICATOR Micromedics, Inc. | GCJ |
| Mar 15, 2011 | K102563 | SINGLE CANNULA EXTENDED APPLICATOR Micromedics, Inc. | KYZ |
| Jun 9, 2010 | K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 Micromedics, Inc. | FMF |
| Mar 14, 2008 | K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 Micromedics, Inc. | MJV |
| Sep 13, 2006 | K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR Micromedics, Inc. | FMF |
| Sep 1, 2005 | K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS Micromedics, Inc. | KCT |
| Apr 27, 2005 | K050340 | MICROMEDICS SPHENOID SINUS STENT Micromedics, Inc. | KAM |
| Feb 11, 2005 | K042834 | MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR Micromedics, Inc. | GCJ |
| Oct 4, 2004 | K033589 | BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR Micromedics, Inc. | FMF |
| Oct 29, 2001 | K012868 | MICROMEDICS FIBRIJET AEROSOL APPLICATOR Micromedics, Inc. | FMF |
| Nov 10, 1999 | K993234 | MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS Micromedics, Inc. | ETB |
| Aug 26, 1999 | K991670 | SILVERSTEIN MICROWICK Micromedics, Inc. | ETD |
| Aug 9, 1999 | K992138 | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES Micromedics, Inc. | ETA |
| Nov 24, 1998 | K982667 | MICROMEDICS NASAL SEPTAL BUTTON Micromedics, Inc. | LFB |
| Apr 6, 1994 | K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP Micromedics, Inc. | KYZ |
| Dec 20, 1991 | K912418 | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE Micromedics, Inc. | KAM |
| Oct 7, 1991 | K911785 | RHINO-GUARD Micromedics, Inc. | CAF |
| Dec 19, 1989 | K895738 | MICROMEDICS EAR, NOSE AND THROAT BURS Micromedics, Inc. | EQJ |
| Oct 13, 1989 | K895739 | MICROMEDICS SURGICAL DRILL SYSTEM Micromedics, Inc. | HBB |
| Aug 23, 1988 | K883338 | SURGICAL SEALANT APPLICATOR Micromedics, Inc. | KYZ |
| Mar 25, 1988 | K881020 | SURGICAL SEALANT DISPENSER (SSD) Micromedics, Inc. | KYZ |
| May 2, 1986 | K860940 | MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT Micromedics, Inc. | ETF |
| Oct 1, 1984 | K842212 | MICROMEDICS SURGICAL INSTRUMENTS Micromedics, Inc. | |
| Oct 19, 1983 | K832068 | CODY SACCULOTOMY TACK Micromedics, Inc. | ESX |
| Oct 14, 1983 | K832680 | MICRO-EDGE DISPOSABLE BLADES Micromedics, Inc. | KDC |
| Mar 7, 1983 | K830228 | OTOLOGICAL VENTILATION TUBES-VARIOUS Micromedics, Inc. | ETD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2016 | Micromedics, Inc. Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide Terminated |
KGZ | None listed |
| Nov 18, 2010 | Micromedics, Inc. VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA.
Terminated |
ETD | None listed |
| Nov 18, 2010 | Micromedics, Inc. SP78100, SP78105
Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard (3cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385.
Nasal Products, Catalog Terminated |
LFB | K982667 |
| Nov 18, 2010 | Micromedics, Inc. ATM100, LB-AP-M0001
Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending Connector), Micromedics, Sterilized by Ethylene Oxide, Rx Only, MicromedicsInc., St Paul, MN 55121-1385.
Distr Terminated |
KYZ | K881020 |
| Nov 18, 2010 | Micromedics, Inc. AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678
Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number
AMS600-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Pau Terminated |
KYZ | K883338 |