9 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314
FDA 510(k)
FDA Class 2
·Cardiovascular
LCP
FDA UDI
Synthes GmbH·10886982167491·2.4MM LCP® RADIAL HEAD RIM PLATE 3 HOLES-LEFT
B. BRAUN BICARBONATE DIALYSATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PERSONA ARTICULAR SURFACE SHIM PROVISIONAL
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code JWH·March 31, 2016
STENOSCOPE
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 19, 2008
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·September 2, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 22, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025