10 results
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17ms
·
Sources: EU EUDAMED, US FDA
PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE
FDA 510(k)
FDA Class 2
·Anesthesiology
Signature
FDA UDI
SILEX MEDICAL, LLC·B3315851024·Fenestrated Straight Grasping Forceps
Signature
FDA UDI
SILEX MEDICAL, LLC·B331585102445·Long Fenestrated Straight Grasping Forceps
Sklar®
FDA UDI
SKLAR CORPORATION·10649111365430·VAN BUREN SOUND 24FR 11"
EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Finger Type Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
VASOVIEW 7 XB
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·February 12, 2014
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·November 29, 2012
UNK PREFILL
FDA Adverse Event
Death
·COVIDIEN·Product code NZW·September 29, 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