7 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DILATION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HANDPIECE SYSTEM I/A
FDA 510(k)
FDA Class 1
·Ophthalmic
SPEC IISX
FDA 510(k)
FDA Class 2
·Neurology
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 28, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 15, 2012
PROVISC IBC
FDA Adverse Event
Malfunction
·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·September 10, 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