Bradshaw Medical Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000003392 FEI 3006846753
- Devices
- 215
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
What Bradshaw Medical Inc. makes
Bradshaw Medical Inc. manufactures reusable surgical instruments for orthopaedic procedures, including screwdrivers, retractors, bone trephines, screw extractors, and orthopaedic fixation kits. Their products also include modular retractor systems and instrument trays designed for general internal orthopaedic surgeries. The company produces reusable screw-extraction reamers and non-medicated orthopaedic surgical procedure kits.
The company’s devices are classified under Class I in the EU and the US, with listings in the EUDAMED registry and the FDA’s Unique Device Identifier (UDI) database. Bradshaw Medical Inc. is based in the United States.
Catalogue
Search and filter all 215 devicesShowing 1-50 of 215
Company details
- EUDAMED SRN
- US-MF-000003392
- FDA FEI number
- 3006846753
- DUNS number
- 621830582
- EUDAMED status
- Active
- EUDAMED registered name
- Bradshaw Medical Inc.
- EUDAMED abbreviated name
- Bradshaw
- Registered address
- 10325 58th Place, 53144, Kenosha, United States
- Website
- www.exalta.com
- facebook.com/weareexalta
- [email protected]
- Phone
- 262-925-1374
- PRRC contact
- Tania Shammo
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 15 Sep 2031
Notified body 2797 1 certificate
- MDR 739879 Reissued
Quality management system EU MDR
- Issued
- 27 Jul 2026
- Expires
- 15 Sep 2031
- Valid from
- 16 Sep 2026
FDA recalls
FDA recall records list 1 recall initiated by Bradshaw Medical Inc., initiated on 2015-02-02. By recorded status: 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.
2015
- 2 Feb 2015 Z-1637-2016 Class II Terminated A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
From the company website
Integrated MedTech OEM partner accelerating device programs from design through market clearance to full-scale commercial launch.
Frequently asked questions
How many devices does Bradshaw Medical Inc. have in the registry?
The registry currently lists 215 devices for Bradshaw Medical Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bradshaw Medical Inc.'s devices?
Among its 50 most recently registered devices, Bradshaw Medical Inc. 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 Bradshaw Medical Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bradshaw Medical Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Bradshaw Medical Inc.?
FDA recall records list 1 recall initiated by Bradshaw Medical Inc., the most recent initiated on 2015-02-02. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Bradshaw Medical Inc.?
EUDAMED lists 1 certificate for Bradshaw Medical Inc. (quality management system) under MDR. The most recent was issued on 2026-07-27.
What are the newest devices from Bradshaw Medical Inc. in the registry?
The most recently registered devices listed for Bradshaw Medical Inc. include FIXED CASE MRS-104-01, Bradshaw Medical Inc. CW-0025-ATEC, Modular Retractor System MRS-100 and MOBILE CASE MRS-104-02.