Micromedics, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000018365 FEI 2183425
Micromedics, Inc. is a medical device manufacturer based in the United States, with 221 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class IIa; FDA Class II, Class I and Unclassified) and 5 FDA recalls as of 15 Nov 2026.
- Devices
- 221
- Registrations
- EUDAMEDFDA
- FDA recalls
- 5
Registry facts
- Registries
- FDA GUDID 154
- EUDAMED 118
- FDA 510(k) 28
- Device classes
- EU Class IIa 118
- FDA Class II 66
- FDA Class I 34
- FDA Unclassified 2
- Top EMDN categories
- Syringes 114
- Tubular devices 4
- FDA recalls
- Sites and related companies
- MDSS GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000018365
- FDA FEI 2183425
- DUNS 066839630
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- MDSS GmbHDE
What Micromedics, Inc. makes
Micromedics, Inc. manufactures surgical devices including open-surgery adhesive/sealant applicators, bone graft delivery kits, irrigation syringes, fibrin sealant biochemical preparation/application kits, endoscopic catheter introducers, ENT cabinets, surgical air pipeline regulators, and wound irrigation cannulas.
The company's portfolio includes Class I, Class II, Class IIa, and U devices, which are listed in eudamed, fda_510k, and fda_udi registries. Micromedics, Inc. is based in the US.
Catalogue
Search and filter all 221 devicesShowing 1-50 of 221
Company details
- EUDAMED SRN
- US-MF-000018365
- FDA FEI number
- 2183425
- DUNS number
- 066839630
- EUDAMED status
- Active
- EUDAMED registered name
- Micromedics, Inc.
- Registered address
- 1270, Eagan Industrial Road, 55121, St. Paul, United States
- Phone
- +1 651.236.7869
- PRRC contact
- Nicole Freeberg
FDA recalls
FDA recall records list 5 recalls initiated by Micromedics, Inc., the earliest on 2010-03-15 and the most recent on 2016-10-20. By recorded status: 5 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 20 Oct 2016 Z-1817-2017 Class II 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.
2010
- 15 Mar 2010 Z-0345-2011 Unclassified (pre-2012) 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.
Full distribution text
- 15 Mar 2010 Z-0346-2011 Unclassified (pre-2012) 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.
Full distribution text
- 15 Mar 2010 Z-0347-2011 Unclassified (pre-2012) 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.
Full distribution text
- 15 Mar 2010 Z-0348-2011 Unclassified (pre-2012) 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.
Full distribution text
- 15 Mar 2010 Z-0345-2011 Unclassified (pre-2012) 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.
Frequently asked questions
How many devices does Micromedics, Inc. have in the registry?
The registry currently lists 221 devices for Micromedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micromedics, Inc.'s devices?
Among its 50 most recently registered devices, Micromedics, Inc. has devices listed in EUDAMED (5 devices), FDA 510(k) (1 device) and FDA GUDID (44 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Micromedics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Micromedics, Inc.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Micromedics, Inc.?
FDA recall records list 5 recalls initiated by Micromedics, Inc., the most recent initiated on 20 Oct 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Micromedics, Inc. in the registry?
The most recently registered devices listed for Micromedics, Inc. include APPLICATOR TIP, INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS, FibriJet and DuploTip.