10 results
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18ms
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Sources: EU EUDAMED, US FDA
i-STAT hs-TnI cartridge with the i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011253051200·ceraMotion® Lf Dentin C2, 20 g / dental ceramic...
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
FDA 510(k)
FDA Class 1
·General Hospital
CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·January 26, 2018
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·December 4, 2008
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 31, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 29, 2013
EQUINOXE COMPRESSION SCREW
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 12, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014