14 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI
FDA 510(k)
FDA Class 2
·General Hospital
Gender Solutions®
FDA UDI
Zimmer, Inc.·00889024205826·
Gender Solutions®
FDA UDI
Zimmer, Inc.·00889024205819·
MARLOW LAPAROSCOPIC GRASPING FORCEP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHARMACIA CMV IGM ELISA
FDA 510(k)
FDA Class 2
·Microbiology
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 18, 2015
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 23, 2013
PROTECTA DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·December 14, 2010
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 27, 2015
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·April 2, 2026
Gender Solutions" Patello-Femoral Component
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·November 6, 2013
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 2, 2016