23 results · 32ms · Sources: EU EUDAMED, US FDA

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HammerTech Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

SYNGO EXPERT-1

FDA 510(k)
FDA Class 2 ·Radiology

INTELLIVUE PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

PENUMBRA MAX PUMP - INDIGO SYSTEM

FDA Adverse Event
Malfunction ·PENUMBRA INC., USA·Product code NRY·August 23, 2018

STELO GLUCOSE BIOSENSOR SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code SAF·June 24, 2025

PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·March 8, 2018

LAMITRODE S8

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

PRECISION LINK

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 10, 2008

DOUBLE MOBILITY LINER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 18, 2025

PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·April 9, 2018

VANGUARD 360 DEGREE TIBIAL TRAY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 20, 2017

VANGUARD SSK 360 FEMORAL

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 20, 2017

VG DA 360 O/S TIB TRAY COCR 75

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·October 1, 2021

VG DA360 TIB BRG ARCM 71/75X16

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·October 1, 2021

VANGUARD DA360 TIB BRG ARCM 71/75X16

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 29, 2021

BIOMET SMOOTH KNEE STEMS 10X40

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 29, 2021

BIOMET SMOOTH KNEE STEM 14X80

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 29, 2021

BIOMET 360 TIB 5.0 OFFSET ADAPTER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 29, 2021

VANGUARD DA 360 O/S TIB TRAY COCR 75

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 29, 2021