14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
HHM
FDA UDI
Sbo Hearing A/S·05714464006540·F30 FW 1.0.0
NEXT Coarse Grape Prophy Paste Box 200
FDA UDI
Preventech·D024220343·NEXT Coarse Grape Prophy Paste Box of 200 2.0g ...
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005251·Pain Control System - Basic
ambiT® "PreSet" Ambulatory Infusion Pump
FDA UDI
Avanos Medical, Inc.·00193494000851·ambIT* Pain Control System - Basic
IM Tibial Guide - Stylus Assembly
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215139674·
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 19, 2021
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 19, 2021
CONNEX WORKSTATION
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SROM NRHFEM W/PIN SM RT 66X62
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KRO·November 3, 2008
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 23, 2011
FORTIFY ASSURA DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025