16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SECURIS SPINAL FIXATION
FDA 510(k)
FDA Class 2
·Orthopedic
Pilot Spinal System
FDA UDI
Life Spine, Inc.·00190837051471·Straight Probe
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
WIN-2 TANGO ELITE NP
FDA 510(k)
FDA Class 2
·Physical Medicine
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
FDA 510(k)
FDA Class 3
·Cardiovascular
EQUINOXE CAGE GLENOID SMALL, ALPHA
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·January 8, 2024
NEXGEN PROVISIONAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020
COLORADO
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER, INC.·Product code GEI·May 2, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
S-ROM STM STD, 30 NK, 16X11X150
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code MRA·May 20, 2011
VANGUARD MONO FINNED STM TIB 71X14
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·December 9, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
VANGUARD ROCC TIB BRG UHMWPE 60X10MM
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
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