10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROMOVE NM900
FDA 510(k)
FDA Class 2
·Physical Medicine
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
FDA 510(k)
FDA Class 2
·Orthopedic
TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·December 3, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
NEXGEN LPS-FLEX GSF FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·September 17, 2014
5MM 0 FULL SCREEN AUTOCLAVABLE LAPAROSCOPE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code GCJ·May 24, 2011
BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·April 29, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025