16 results · 20ms · Sources: EU EUDAMED, US FDA

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B. FRAGTEX

FDA 510(k)
FDA Class 1 ·Microbiology

SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

FDA Enforcement
Class II ·Completed·Townsend Design·January 17, 2024

THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

LnK Lumbar Interbody Fusion Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 18, 2014

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 18, 2010

EON PATIENT PROGRAMMER

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 17, 2012

BIOMET FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019

BIOMET FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019

BIOMET (R) INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019

VANGUARD (TM) PS OPEN BOX FEMORAL RIGHT INTERLOK

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HRY·April 23, 2019

VANGUARD (TM) E-POLY (TM) PS TIBIAL BEARING

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HRY·April 23, 2019

VANGUARD (TM) E-POLY (TM) PS TIBIAL BEARING

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HRY·April 23, 2019

BIOMET ARCOM ALL POLY PAT. BUTTON

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019

BIOMET (R) INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 23, 2019

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020