Midmark Corporation
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000002581 FEI 1523530
Midmark Corporation is a medical device manufacturer based in the United States, with 1,613 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class I) and 8 FDA recalls as of 13 Nov 2026.
- Devices
- 1,613
- Registrations
- EUDAMEDFDA
- FDA recalls
- 86 ongoing
Registry facts
- Registries
- FDA GUDID 1,574
- EUDAMED 212
- FDA 510(k) 39
- Device classes
- FDA Class I 820
- FDA Class II 608
- EU Class I 179
- Top EMDN categories
- FDA recalls
- Sites and related companies
- CEpartner4U authorised representative
- Identifiers
- EUDAMED SRN US-MF-000002581
- FDA FEI 1523530
- DUNS 005036025
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- CEpartner4UNL
What Midmark Corporation makes
Midmark Corporation manufactures stationary intraoral digital dental X-ray systems, electric and examination dental chairs with reusable headrests, intraoral digital imaging sensors, LED and reflective dental lighting, dental suction units, and steam sterilizers for dental offices.
The company’s products are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Midmark Corporation is based in the United States.
Catalogue
Search and filter all 1,613 devicesShowing 1-50 of 1,613
Company details
- EUDAMED SRN
- US-MF-000002581
- FDA FEI number
- 1523530
- DUNS number
- 005036025
- EUDAMED status
- Active
- EUDAMED registered name
- Midmark Corporation
- EUDAMED abbreviated name
- Midmark
- Registered address
- 60, Vista Drive, 45380, Versailles, United States
- Website
- www.midmark.com
- facebook.com/MidmarkCorporation
- Phone
- +1(800)643-6275
- PRRC contact
- Adam Clutter
FDA recalls
FDA recall records list 7 recalls initiated by Midmark Corporation, the earliest on 2003-03-05 and the most recent on 2026-08-21. By recorded status: 6 ongoing and 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 6
2026
- 21 Aug 2026 Z-3217-2026 Class II Ongoing A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- 21 Aug 2026 Z-3218-2026 Class II Ongoing A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- 21 Aug 2026 Z-3219-2026 Class II Ongoing A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- 21 Aug 2026 Z-3220-2026 Class II Ongoing A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- 20 Jul 2026 Z-3012-2026 Class II Ongoing A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
- 20 Jul 2026 Z-3013-2026 Class II Ongoing A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
2011
- 24 Oct 2011 Z-0597-2012 Unclassified (pre-2012) Terminated During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.
Full distribution text
- 24 Oct 2011 Z-0597-2012 Unclassified (pre-2012) Terminated During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.
2003
- 5 Mar 2003 Z-0704-03 Unclassified (pre-2012) Terminated The pressure relief valve may fail to open properly.
Full distribution text
- 5 Mar 2003 Z-0704-03 Unclassified (pre-2012) Terminated The pressure relief valve may fail to open properly.
From the company website
Midmark is a global manufacturer and supplier of healthcare products, equipment and diagnostic software for medical, veterinary, and dental markets.
Frequently asked questions
How many devices does Midmark Corporation have in the registry?
The registry currently lists 1613 devices for Midmark Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Midmark Corporation's devices?
Among its 50 most recently registered devices, Midmark Corporation has devices listed in FDA GUDID (50 devices).
What risk classes do Midmark Corporation's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Midmark Corporation's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Midmark Corporation?
FDA recall records list 8 recalls initiated by Midmark Corporation, the most recent initiated on 21 Aug 2026. 6 of them are recorded as ongoing. 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 Midmark Corporation in the registry?
The most recently registered devices listed for Midmark Corporation include Midmark 153810-001, Midmark 153810-002, Midmark 153810-003 and Midmark 153600-020.