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

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PHYSIOFLOW SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

TERUMO NEEDLE WITH LOCKING SHEATH

FDA 510(k)
FDA Class 2 ·General Hospital

MYALLERGYTEST SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

LIFESTENT FLEXSTAR XL BILIARY STENT

FDA Adverse Event
Injury ·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008

LIFESTENT FLEXSTAR XL BILIARY STENT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008

LIFESTENT FLEXSTAR XL BILIARY STENT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009

LIFESTENT FLEXSTAR XL BILIARY STENT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008

LIFESTENT FLEXSTAR XL BILIARY STENT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·April 15, 2011

BRACHYVISION

FDA Adverse Event
Injury ·VARIAN MEDICAL SYSTEMS·Product code MUJ·June 12, 2008

EVOLUT FX VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 9, 2025

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018