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

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PHYSIOGLOVE ES

FDA 510(k)
FDA Class 2 ·Cardiovascular

CT LUCIA

FDA UDI
CARL ZEISS MEDITEC PRODUCTION, LLC·00843045100959·3-piece, monofocal, hydrophobic, acrylic, intra...

BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD

FDA 510(k)
FDA Class 2 ·Neurology

CT LUCIA 602

FDA Adverse Event
Injury ·CARL ZEISS MEDITEC PRODUCTION LLC·Product code HQL·December 21, 2022

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 10, 2013

RIATA ST OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011

G7 DUAL MOBILITY LINER 50MM H

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 13, 2021

VIVACIT-E DM BEARING 28X50MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 13, 2021

G7 OSSEOTI 4 HOLE SHELL 64MM H

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 13, 2021

CER OPTION TYPE 1 TPR SLEVE +6

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·September 28, 2021

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORP.·Product code NIQ·August 11, 2006

CT LUCIA 602

FDA Adverse Event
Injury ·CARL ZEISS MEDITEC PRODUCTION LLC·Product code HQL·November 23, 2022

TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021