7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GUIDE, WIRE, ANGIOGRAPHIC
FDA 510(k)
FDA Class 2
·Cardiovascular
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams
FDA 510(k)
FDA Class 2
·Orthopedic
TRIDENT HEMISPHERICAL MULTI
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·November 21, 2012
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOD MEDICAL DEVICES GROUP·Product code FRN·March 21, 2014
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·September 28, 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