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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

COBAS CORE IMMUNOCHEMISTRY SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ZMR®

FDA UDI
Zimmer, Inc.·00889024156814·

ZMR®

FDA UDI
Zimmer, Inc.·00889024156807·

ZMR®

FDA UDI
Zimmer, Inc.·00889024156821·

ZMR®

FDA UDI
Zimmer, Inc.·00889024156838·

Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments

FDA 510(k)
FDA Class 2 ·Neurology

CANDELA VBEAM PULSED DYE LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AGC DA2000 KN TIB BRG 71/75X14

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·August 31, 2016

BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM

FDA Adverse Event
Malfunction ·BIOMET ORTHOPEDICS·Product code HRY·June 16, 2017

E1 RINGLOC BIPOLAR 28X51MM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019

AGC V2 INTERLOK TIB 10X 71MM

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code HRX·May 19, 2017

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·January 17, 2013

AUTOMATED PD SET W/CASSETTE4 PRONG

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 13, 2010

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2014

AGC V2 INTERLOK TIB 8 X 75MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·April 12, 2017

BIOMEX SHELL PC DIA48MM LN 22

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 2, 2015

AGC V2 INTERLOK TIB 8 X 79MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·March 22, 2016

REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·July 17, 2013

AGC REVISION KNEE TIBIAL AUGMENTATION

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·June 28, 2017