22 results · 24ms · Sources: EU EUDAMED, US FDA

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physIQ Heart Rhythm and Respiratory Module

FDA 510(k)
FDA Class 2 ·Cardiovascular

CoRoent

FDA UDI
Nuvasive, Inc.·00887517639042·CoRoent Ant TLIF PEEK, 8x13x32mm 12°

Vanguard® SSK Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304440913·

EVERCROSS 0.035 OTW PTA DILATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

NEUROMETRIX BIOAMPLIFIER

FDA 510(k)
FDA Class 2 ·Neurology

STYLE 68 SALINE FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FWM·February 29, 2024

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·December 6, 2021

ADVIA CENTAUR XP

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·October 17, 2014

HIP 2.3 CURVED SYSTEM

FDA Adverse Event
Malfunction ·SMITH & NEPHEW ASDD·Product code NBH·July 28, 2011

CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code HXX·June 21, 2013

Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151

FDA Enforcement
Class II ·Terminated·Cook Inc.·February 12, 2020

VNGD SSKPSC TIB BRG S 12X63/67

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 3, 2025

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EYB·July 2, 2024

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·February 28, 2022

VANGAURD SSK INTERLOCKING FEMORAL

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018

VANGUARD DISTAL FEMORAL AUGMENT 60X5 LL/RM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·August 11, 2017

BIOMET SPLINED KNEE STEM 14X80

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·August 11, 2017

VANGUARD SSKPSC TIBIAL BEARING S 12X63/67

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 21, 2017

VANGUARD DISTAL FEMORAL AUGMENT 60X5 RL/LM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·August 11, 2017

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code EZL·July 8, 2022