23 results
·
27ms
·
Sources: EU EUDAMED, US FDA
L12 LED Light Source with AIM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Icona Hip Stem
FDA UDI
CORIN LTD·05056139247132·ICONA STEM STANDARD COLLARED STEM SIZE 8
STAR
FDA UDI
Stryker GmbH·00886385018584·PE Trial, Size 14
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037310977·HUMELOCK II TRIAL LONG STEM LG200mm T08
SOLUTION SYSTEM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295148883·SOLUTION SYSTEM TEMPLATE - STRAIGHT 8in
SOLUTION SYSTEM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295148890·SOLUTION SYSTEM 8 IN STRAIGHT KIT COMPLETE
SOLUTION SYSTEM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295148876·SOLUTION SYSTEM TRIAL TRAY 10 IN L/R
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Synapse PACS
FDA 510(k)
FDA Class 2
·Radiology
IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 23, 2024
IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·March 18, 2025
CAROTID WALLSTENT?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIM·November 18, 2014
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC·Product code JJE·August 26, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·August 1, 2013
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020