10 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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ExcelsiusXR
FDA 510(k)
FDA Class 2
·Neurology
ELMED
FDA UDI
ELMED INCORPORATED·00842180159037·multi flex neuro large instr holder 2" dia shaft
APPLE ECG (ELECTROCARDIOGRAPH) APP
FDA Adverse Event
Injury
·APPLE INC.·Product code QDA·July 5, 2023
ECG App
FDA 510(k)
FDA Class 2
·Cardiovascular
HEMOVAC BLOOD REINFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DXTEND SCREW NO LOCK D4.5X18MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC 1818910·Product code KWS·December 27, 2017
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 25, 2008
11MM X 150MM POLARUS LOCKING HUMERAL ROD
FDA Adverse Event
Malfunction
·ACUMED LLC·Product code HSB·September 9, 2011
FEMORAL HEAD
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code MRA·July 22, 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