7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EPSILON TSH TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Advanta VXT Vascular Graft, Flixene Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 14, 2012
M/G UNICOMPARTMENTAL TENSION GAUGE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LXH·September 7, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015