10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Iconic Nitrile Glove
FDA 510(k)
FDA Class 1
·General Hospital
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 5, 2021
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
FDA 510(k)
FDA Class 2
·Radiology
ANGIOSCULPT PTA SCORING BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2018
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 18, 2015
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025