10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Copioumed AAMI 3 Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
FDA 510(k)
FDA Class 2
·Anesthesiology
Infinity CentralStation Wide
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 23, 2012
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 13, 2024
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·April 20, 2012
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·September 16, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Death
·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 5, 2014
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 25, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024