7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SURGITEK PERCUTANEOUS NEPHROST. STENT
FDA 510(k)
FDA Unclassified
·Unknown
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
KSEA QUADRO SWITCH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 6, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·August 26, 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