Accutron
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000009363 FEI 2020813
Accutron is a medical device manufacturer based in the United States, with 666 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class IIa and IIb) and 4 FDA recalls as of 13 Nov 2026.
- Devices
- 666
- Registrations
- EUDAMEDFDA
- FDA recalls
- 4
Registry facts
- Registries
- FDA GUDID 661
- EUDAMED 161
- FDA 510(k) 5
- Device classes
- FDA Class I 340
- FDA Class II 198
- EU Class IIa 98
- EU Class IIb 30
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Medical Technology Promedt Consulting GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000009363
- FDA FEI 2020813
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Medical Technology Promedt Consulting GmbHDE
Catalogue
Search and filter all 666 devicesShowing 1-50 of 666
Company details
- EUDAMED SRN
- US-MF-000009363
- FDA FEI number
- 2020813
- EUDAMED status
- Active
- EUDAMED registered name
- ACCUTRON
- Registered address
- 1625, W Pinnacle Peak Rd., 85027, Phoenix, United States
- PRRC contact
- Jennifer Rieck
FDA recalls
2012
- 29 Apr 2012 Z-0017-2013 Class I Terminated Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
- 29 Apr 2012 Z-0018-2013 Class I Terminated Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
- 29 Apr 2012 Z-0019-2013 Class I Terminated Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
- 29 Apr 2012 Z-0020-2013 Class I Terminated Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Frequently asked questions
How many devices does ACCUTRON have in the registry?
The registry currently lists 666 devices for ACCUTRON. Devices recorded under merged duplicate company entries are counted once.
Which registries list ACCUTRON's devices?
Among its 50 most recently registered devices, ACCUTRON has devices listed in EUDAMED (2 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ACCUTRON's devices fall under?
Among its 50 most recently registered devices, the classes recorded for ACCUTRON's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ACCUTRON?
FDA recall records list 4 recalls initiated by ACCUTRON, the most recent initiated on 29 Apr 2012. 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 ACCUTRON in the registry?
The most recently registered devices listed for ACCUTRON include Chemtron O2 Q/C Hose________FT. 34085-CUSTOM, WAGD Chemetron x 1/2" MNPT 34976, Manifold With Wall Alarm, C (2+1), NP 38004-NP and Riser, FRU, O2, Cylinder Room 27752.