10 results
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20ms
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Sources: EU EUDAMED, US FDA
Spectrum-2
FDA 510(k)
FDA Class 2
·Cardiovascular
Ecomed Disposable Administration Sets
FDA 510(k)
FDA Class 2
·General Hospital
AViTA Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMP TM 3.7MM MTX FULL,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·March 18, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
TIMESH STRAIGHT PLATE, 1 X 1, 12MM SHAFT
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JEY·August 18, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 30, 2013
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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