Micromedics, Inc.
Saint Paul, MN, US
MICROMEDICS, INC. appears in FDA device records in Saint Paul, MN. FDA records list 29 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 29 510(k) clearances for Micromedics, Inc. between 1983 and 2024. The busiest year on record is 1983, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 3 |
| 1984 | 1 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 2 |
| 1991 | 2 |
| 1994 | 1 |
| 1998 | 1 |
| 1999 | 3 |
| 2001 | 1 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241739 | Endoscopic Applicator, 41 cm | GCJ | Substantially Equivalent | |
| K123847 | MALLEABLE TIP ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | |
| K122526 | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | |
| K120608 | ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | KYZ | Substantially Equivalent | |
| K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 | FMF | Substantially Equivalent | |
| K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | MJV | Substantially Equivalent | |
| K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR | FMF | Substantially Equivalent | |
| K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS | KCT | Substantially Equivalent | |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | KAM | Substantially Equivalent | |
| K042834 | MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR | GCJ | Substantially Equivalent | |
| K033589 | BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR | FMF | Substantially Equivalent | |
| K012868 | MICROMEDICS FIBRIJET AEROSOL APPLICATOR | FMF | Substantially Equivalent | |
| K993234 | MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | ETB | Substantially Equivalent | |
| K991670 | SILVERSTEIN MICROWICK | ETD | Substantially Equivalent | |
| K992138 | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES | ETA | Substantially Equivalent | |
| K982667 | MICROMEDICS NASAL SEPTAL BUTTON | LFB | Substantially Equivalent | |
| K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | KYZ | Substantially Equivalent | |
| K912418 | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE | KAM | Substantially Equivalent | |
| K911785 | RHINO-GUARD | CAF | Substantially Equivalent | |
| K895738 | MICROMEDICS EAR, NOSE AND THROAT BURS | EQJ | Substantially Equivalent | |
| K895739 | MICROMEDICS SURGICAL DRILL SYSTEM | HBB | Substantially Equivalent | |
| K883338 | SURGICAL SEALANT APPLICATOR | KYZ | Substantially Equivalent | |
| K881020 | SURGICAL SEALANT DISPENSER (SSD) | KYZ | Substantially Equivalent | |
| K860940 | MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT | ETF | Substantially Equivalent | |
| K842212 | MICROMEDICS SURGICAL INSTRUMENTS | Substantially Equivalent | ||
| K832068 | CODY SACCULOTOMY TACK | ESX | Substantially Equivalent | |
| K832680 | MICRO-EDGE DISPOSABLE BLADES | KDC | Substantially Equivalent | |
| K830228 | OTOLOGICAL VENTILATION TUBES-VARIOUS | ETD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183425 | 2183425 | MICROMEDICS, INC. | 1270 Eagan Industrial Road, Saint Paul, MN 55121 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- EQJBur, Ear, Nose And Throat
- LFBButton, Nasal Septal
- KAMCannula, Sinus
- GEACannula, Surgical, General & Plastic Surgery
- MJVDevice, Inflation, Middle Ear
- KDCInstrument, Surgical, Disposable
- GCJLaparoscope, General & Plastic Surgery
- HBBMotor, Drill, Pneumatic
- CAFNebulizer (Direct Patient Interface)
- ETBProsthesis, Partial Ossicular Replacement
- CANRegulator, Pressure, Gas Cylinder
- ETAReplacement, Ossicular Prosthesis, Total
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- ESXTack, Sacculotomy (Cody Tack)
- ETDTube, Tympanostomy
- ETFUnit, Examining/Treatment, Ent
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1817-2017 | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide | The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance. | Class II | Terminated | |
| Z-0348-2011 | 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. VT-0204-01 Otological Ventilation Tubes, Catalog Number VT-0204-01, Shepard, 1.0 mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0406-01 Otological Ventilation Tubes, Catalog Number VT-0406-01, T-Tube, 5mm x 4mm x 1.14mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-01 Otological Ventilation Tubes, Catalog Number VT-0503-01, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-50 Otological Ventilation Tubes, Catalog Number VT-0503-50, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0507-01 Otological Ventilation Tubes, Catalog Number VT-0507-01, Armstrong Grommet w/wire, 1.14mm Lumen, FL, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT0508-50 Otological Ventilation Tubes, Catalog Number VT-0508-50, Modified Armstrong Grommet 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1002-50 Otological Ventilation Tubes, Catalog Number VT-1002-50, Collar Button, 1.27mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1035-01 Otological Ventilation Tubes, Catalog Number VT-1035-01, Collar Button, 1.5mm Lumen, Titanium, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT1204-01 Otological Ventilation Tubes, Catalog Number VT-1204-01, Reuter Bobbin 1.14mm , Lumen, FL Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1421-01 Otological Ventilation Tubes, Catalog Number VT-1421-01, Angled Tab Bobbin 1.27mm Lumen, TI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. ET-ABGDT-45 Distributed By API Anthony products, Inc., ET-ABGDT-45 Armstrong Grommet, 1.14mm Lumen, FP Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-GTST-45-12, Distributed By API Anthony products, Inc., ET-GTST-45-12, T-tube 12 x 10, 1.14mm Lumen, SI , Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-SPDT-40T, Distributed By API Anthony products, Inc., ET-SPDT-40T Shea Parasol w/Tab, 1.0mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-TBDT-45 Distributed By API Anthony products, Inc., ET-TBDT-45 Reuter Bobbin w/c Holes 1.14mm Lumen, FP, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection. | Terminated | ||
| Z-0347-2011 | 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 Number SP-78105, Nasal Septal Button Oversize (5cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385. | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection. | Terminated | ||
| Z-0346-2011 | 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. Distributed by Lifebond, P.O. Box 3048 Caesarea Industrial Park 38900, Israel, LP-AP-M0001, LifeSeal SLR Applicator Sterilized by Ethylene Oxide, Manufactured By Micromedics, St Paul, MN 55121-1385 USA. | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches potentially resulting in a non-sterile product which may cause transmission of disease or infection. | Terminated | ||
| Z-0345-2011 | 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. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number AMS700-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. Fibrijet, Applicator Tip Dual Cannula Malleable 26 ga x3" (7.6cm), Catalog Number SA-0105, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. Fibrijet, Mixing Applicator Tip Low Viscosity with Spray Tip, Catalog Number SA-3675, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. Fibrijet, Blending Connector with Mixer, Catalog Number SA-3678, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain