9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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uCT 780
FDA 510(k)
FDA Class 2
·Radiology
GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
FDA 510(k)
FDA Class 2
·Anesthesiology
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
OPTIVANTAGE DH
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code DXT·October 6, 2017
V.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code JCX·November 20, 2008
CSF - VENTRICULAR CATHETER, STANDARD, 23CM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·August 17, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013
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