12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033441·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...
CASTLE MODEL 233HC STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
ISOLA POLYAXIAL WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA Adverse Event
Injury
·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022
SUPERTRAX
FDA Adverse Event
Malfunction
·SUPERDIMENSON, LTD.·Product code GAA·February 14, 2013
VERITAS COLLAGEN MATRIX
FDA Adverse Event
Injury
·SYNOVIS SURGICAL INNOVATIONS·Product code FTM·March 24, 2011
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·April 21, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
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