8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
MULTITREAT 48
FDA 510(k)
FDA Class 2
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704262131·
ULTRA ZYME PLUS GAMMA GT #65055 & 56
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DISPOSABLE MICROTOME BLADE
FDA 510(k)
FDA Class 1
·Pathology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 15, 2012
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 14, 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