14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HIP SAVER
FDA 510(k)
FDA Class 1
·Physical Medicine
LEONE SPA
FDA UDI
LEONE SPA·08033707034094·WEB 1ST MOL BANDS W/G8084-12 KIT UR
9131 DEFIBRILLATION ELECTRODES
FDA 510(k)
FDA Class 3
·Cardiovascular
AposTherapy System
FDA 510(k)
FDA Class 1
·Physical Medicine
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 8, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 8, 2024
ATLAS PLUS HF CRT-D
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·June 18, 2014
VANGUARD CR FEMORAL 60MM RIGHT INTERLOK
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code JWH·October 25, 2010
MENISCAL CINCH, CURVED TIP
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code GAT·December 20, 2012
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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