9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
C-POST
FDA 510(k)
FDA Class 1
·Dental
N/A
FDA UDI
Tyber Medical, LLC·M695M9453700·
EXACTECH BIPOLAR HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
COPPER VAPOR LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
4.5MM CANNULATED SCREW, FULLY THREADED
FDA Adverse Event
Malfunction
·SYNTHES (USA) MONUMENT·Product code HWC·February 1, 2013
PINN MAR NEUT 32IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 30, 2010
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 2, 2014
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·September 8, 2025
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019