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