9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
COMPUTER AUDIOMETER - MA26
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Cellvizio 100 Series Systems with Confocal Miniprobes
FDA 510(k)
FDA Class 2
·Neurology
MANUAL RIGID MOBILITY WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 5, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 12, 2007
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 3, 2013
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 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