9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
Panther TPS
FDA 510(k)
FDA Class 2
·Radiology
C.CAM
FDA 510(k)
FDA Class 2
·Radiology
12.5 FR (4.2 MM) (.166 IN.) PEEL-AWAY CATHETER INTRODUCER
FDA Adverse Event
Injury
·RAYNHAM·Product code GYK·September 15, 2022
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 27, 2014
ASR XLA M/L SLEEVE 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 8, 2010