14 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MultiStage Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LCP
FDA UDI
Synthes GmbH·10886982157423·4.5MM LCP® CONDYLAR PLATE 12 HOLES/278MM-LEFT
KERADEC
FDA 510(k)
FDA Class 2
·Dental
ORAMOIST
FDA 510(k)
FDA Unclassified
·Unknown
LOGICAL 84" SINGLE MONITORING LINE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL·Product code DRS·July 17, 2008
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·May 1, 2018
PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION·Product code LIT·November 3, 2008
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code GCJ·July 7, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 12, 2013
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
BD KIESTRA¿ IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·December 9, 2024
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 13, 2018
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·May 17, 2018
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026