7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTICATH
FDA 510(k)
FDA Class 2
·Cardiovascular
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 2, 2012
IMPLANTIUM
FDA Adverse Event
Injury
·DENTIUM USA·Product code DZE·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