Pro-Dex, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000010685 FEI 2081135
Pro-Dex, Inc. is a medical device manufacturer based in the United States, with 38 devices listed in FDA GUDID and EUDAMED (FDA Class I and II; EU Class IIa and I) and 7 FDA recalls as of 14 Nov 2026.
- Devices
- 38
- Registrations
- EUDAMEDFDA
- FDA recalls
- 73 ongoing
Registry facts
- Registries
- FDA GUDID 38
- EUDAMED 16
- Device classes
- FDA Class I 20
- EU Class IIa 9
- EU Class I 7
- FDA Class II 2
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Eurolink Europe Compliance Limited authorised representative
- Identifiers
- EUDAMED SRN US-MF-000010685
- FDA FEI 2081135
- DUNS 849370358
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Eurolink Europe Compliance LimitedIE
Catalogue
Search and filter all 38 devicesCompany details
- EUDAMED SRN
- US-MF-000010685
- FDA FEI number
- 2081135
- DUNS number
- 849370358
- EUDAMED status
- Active
- EUDAMED registered name
- Pro-Dex, Inc.
- Registered address
- 2361 McGaw Ave, 92614, Irvine, United States
- Website
- www.pro-dex.com/
- sales@pro-dex.com
- Phone
- +1 949-769-3200
- PRRC contact
- Angel Domingo
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 2
- 2024 1
- 2025 0
- 2026 0
2024
- 23 Sep 2024 Z-0280-2025 Class II Ongoing The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
2023
- 15 Feb 2023 Z-2098-2023 Class II Ongoing Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
- 14 Feb 2023 Z-1391-2023 Class II Ongoing Incorrect Unique Device Identifier/GTIN code was used on product.
2018
- 25 Sep 2018 Z-2340-2019 Class II Terminated Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
2015
- 23 Dec 2015 Z-1094-2016 Class II Terminated The sterile battery may contain particulates within the sterile package.
- 23 Dec 2015 Z-1095-2016 Class II Terminated The sterile battery may contain particulates within the sterile package.
2009
- 19 Jan 2009 Z-1212-2010 Unclassified (pre-2012) Terminated Pro-Dex has initiated a recall on their Dental Torque Wrench. The recall was initiated due to an inaccurate laser etch identification of the torque value.
Frequently asked questions
How many devices does PRO-DEX, INC. have in the registry?
The registry currently lists 38 devices for PRO-DEX, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list PRO-DEX, INC.'s devices?
Among its 38 most recently registered devices, PRO-DEX, INC. has devices listed in EUDAMED (16 devices) and FDA GUDID (38 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do PRO-DEX, INC.'s devices fall under?
Among its 38 most recently registered devices, the classes recorded for PRO-DEX, 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 PRO-DEX, INC.?
FDA recall records list 7 recalls initiated by PRO-DEX, INC., the most recent initiated on 23 Sep 2024. 3 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 PRO-DEX, INC. in the registry?
The most recently registered devices listed for PRO-DEX, INC. include MatrixPRO II Handpiece Loaner 05.000.030LN, Zimmer Biomet 90D Atlas Blade APD-B90-201, BATTERY PACK, KLS-SD-1000, SINGLE KLS-BP-001 and Zimmer Biomet Atlas Pro Driver APD-1000-4.