9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ScanX Barrier Envelopes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
BICERA (TM) RESORBABLE BONE SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·September 29, 2025
VISUM LED WEIGHTED LIGHT HANDLE
FDA Adverse Event
Malfunction
·STRYKER COMMUNICATIONS·Product code FSY·July 19, 2011
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 14, 2013
USS LOW PROFILE FRACTURE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·October 21, 2014
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. 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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018