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

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MOSS 100 Pedicle Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

HairCheck-DT (Cocaine)

FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

Bernafon

FDA UDI
Bernafon AG·05711584058800·SU7 P, VC PS MSIL/MAC SUITE 7

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

GMK NARROW

FDA 510(k)
FDA Class 2 ·Orthopedic

REPROCESSED ELECTROPHYSIOLOGY CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017

GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019

COATED VICRYL

FDA Adverse Event
Malfunction ·ETHICON, INC·Product code GAM·July 8, 2011

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 11, 2013

TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·September 3, 2008

GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022

GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016

GMK PS TIBIAL INSERT SIZE 3 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024