8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209116799·
Caremed patient cable and leadwires
FDA 510(k)
FDA Class 2
·Cardiovascular
REPROCESSED BALOON INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
HIRES 90K IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·April 2, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 30, 2012
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code LFR·June 18, 2015
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