15 results · 22ms · Sources: EU EUDAMED, US FDA

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O_TWO CPAP SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

CHITOGAUZE

FDA 510(k)
FDA Unclassified ·Unknown

OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 8, 2013

SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 12, 2012

SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012

TRIGEN INSTRUMENTS

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code LXH·May 14, 2013

DISPOSABLE HEMOSTASIS CLIP

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code MND·May 26, 2011

LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDO·August 11, 2008

SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 14, 2013

SUPRA VERITAS BILIARY STENT DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012

SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 28, 2012

WALLFLEX? BILIARY TRANSHEPATIC

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025