11 results · 27ms · Sources: EU EUDAMED, US FDA

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CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033394·Baltic Denture System BDLoad BDLoad Lm6 PLSEbi...

LIFTLOC SAFETY INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

APPALEAD GW+03XXXXXXR SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

OASYS BLOCKER

FDA Adverse Event
Injury ·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015

TRAPSYSTEM NEEDLE AND TRAP

FDA Adverse Event
Malfunction ·HS MEDICAL INC·Product code KNW·March 18, 2013

BIPOLAR CUTTING ELECTRODE

FDA Adverse Event
Malfunction ·RICHARD WOLF MEDICAL INSTRUMENTS·Product code FAS·March 22, 2011

SYNTHES

FDA Adverse Event
Injury ·SYNTHES·Product code HRS·April 22, 2008

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

FDA Enforcement
Class I ·Terminated·St Jude Medical Inc.·November 2, 2016