7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INSPIRON LIQUID OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DORC CONTACT/PHOTO DERATOSCOPE
FDA 510(k)
FDA Class 1
·Ophthalmic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 15, 2012
VIVA XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2015
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