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Sign in to claim this brandMicromedics, Inc.
United States·US-MF-000018365
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1270, Eagan Industrial Road , St. Paul, United States
- Website
- nordsonmedical.com
- —
- —
- [email protected]
- Phone
- +1 651.236.7869
- PRRC Contact
- Nicole Freeberg
- EUDAMED SRN
- US-MF-000018365
- FDA FEI Number
- 2183425
- DUNS Number
- 066839630
Catalogue (231)
Page 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Earpopper, Model Ep-2000, Ep-2100, Ep-3000 | K073401 | FDA 510(k) | U | Active |
| Cody Sacculotomy Tack | K832068 | FDA 510(k) | Class II | Active |
| Single Cannula Extended Applicator | K102563 | FDA 510(k) | Class I | Active |
| Baxter Duplotip Surgical Sealant Applicator | K033589 | FDA 510(k) | Class II | Active |
| Micromedics Ear, Nose And Throat Burs | K895738 | FDA 510(k) | Class I | Active |
| Micromedics S&T Partial Ossicular Replacement Prosthesis | K993234 | FDA 510(k) | Class II | Active |
| Shikani Middle Meatal Antrostomy Vent Tube | K912418 | FDA 510(k) | Class I | Active |
| 360 Gas Assisted Endoscopic Applicator | K122526 | FDA 510(k) | Class II | Active |
| Micromedics Fibrijet Aerosol Applicator | K012868 | FDA 510(k) | Class II | Active |
| Silverstein Microwick | K991670 | FDA 510(k) | Class II | Active |
| Micromedics Sterile, Disposable Ent Exam Kit | K860940 | FDA 510(k) | Class I | Active |
| Surgical Sealant Applicator Tip Endoscopic Tip | K940371 | FDA 510(k) | Class I | Active |
| Baxter Duplospray Mis Applicator | K061092 | FDA 510(k) | Class II | Active |
| Micromedics Nasal Septal Button | K982667 | FDA 510(k) | U | Active |
| Micromedics Surgical Drill System | K895739 | FDA 510(k) | Class II | Active |
| Micromedics S&T Total Ossicular Replacement Prosthesis And Accessories | K992138 | FDA 510(k) | Class II | Active |
| Surgical Sealant Applicator | K883338 | FDA 510(k) | Class I | Active |
| Malleable Tip Endoscopic Applicator | K123847 | FDA 510(k) | Class II | Active |
| Surgical Sealant Dispenser (ssd) | K881020 | FDA 510(k) | Class I | Active |
| Graft Delivery System Model Sa-6115 | K100754 | FDA 510(k) | Class II | Active |
| Micromedics Sphenoid Sinus Stent | K050340 | FDA 510(k) | Class I | Active |
| Micro-Edge Disposable Blades | K832680 | FDA 510(k) | Class I | Active |
| Endoscopic Applicator, 41 cm | K241739 | FDA 510(k) | Class II | Active |
| Otological Ventilation Tubes-Various | K830228 | FDA 510(k) | Class II | Active |
| Rhino-Guard | K911785 | FDA 510(k) | Class II | Active |
| FibriJet | SA-3648 | EUDAMEDFDA UDI | Class IIa | Active |
| Magellan Despenser Tip | AMS700 | EUDAMEDFDA UDI | Class IIa | Active |
| OsteoPrecision | GD-1015-150-ND | EUDAMED | Class IIa | Active |
| FibriJet | SA-3619 | EUDAMEDFDA UDI | Class IIa | Active |
| LifeSpine | LS-1015-150Z | EUDAMEDFDA UDI | Class IIa | Active |
| Arthrex Applicator | ABS-10051 | EUDAMEDFDA UDI | Class IIa | Active |
| Baxter Endoscopic Applicator | 0600127 | EUDAMEDFDA UDI | Class IIa | Active |
| FibriJet | SA-3600 | EUDAMEDFDA UDI | Class IIa | Active |
| FibriJet | SA-3615 | EUDAMEDFDA UDI | Class IIa | Active |
| DuploSpray MIS | 0601129 | EUDAMEDFDA UDI | Class IIa | Active |
| FibriJet | SA-3650 | EUDAMED | Class IIa | Active |
| Magellen Dispenser Tip | AMS607 | EUDAMED | Class IIa | Active |
| OsteoXpress | GD-5515 | EUDAMEDFDA UDI | Class IIa | Active |
| Megellan Dispenser Tip | AMS607 | EUDAMEDFDA UDI | Class IIa | Active |
| FibriJet | SA-3648 | EUDAMED | Class IIa | Active |
| Arthrex Applicator | ABS-10050 | EUDAMEDFDA UDI | Class IIa | Active |
| OsteoPrecision Graft Delivery Device | GD-1015-150 | EUDAMED | Class IIa | Active |
| DuploSpray | 0600030 | EUDAMED | Class IIa | Active |
| FibriJet | SA-3652 | EUDAMEDFDA UDI | Class IIa | Active |
| FibriJet | SA-3305 | EUDAMED | Class IIa | Active |
| Spray Set 360 Endoscopic Applicator with Snap Lock | 0611128 | EUDAMEDFDA UDI | Class IIa | Active |
| Magellan Dispenser Tip | AMS600 | EUDAMEDFDA UDI | Class IIa | Active |
| Exactech Accelerate | 620-00-02 | EUDAMED | Class IIa | Active |
| DuploSpray MIS | 0600031 | EUDAMEDFDA UDI | Class IIa | Active |
| DuploSpray | 0601130 | EUDAMED | Class IIa | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 20, 2016 | Z-1817-2017 | — | terminated | 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. |
| Mar 15, 2010 | Z-0347-2011 | — | terminated | 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. |
| Mar 15, 2010 | Z-0348-2011 | — | terminated | 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. |
| Mar 15, 2010 | Z-0346-2011 | — | terminated | 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. |
| Mar 15, 2010 | Z-0345-2011 | — | terminated | 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. |