15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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