10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
actiTENS mini
FDA 510(k)
FDA Class 2
·Neurology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813053966·PVS IMP MAT MB 50ML RS MINT
COBAS® WNV (192T)
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 22, 2025
AFIBALERT ATRIAL FIBRILLATION DETECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OTC12D AUTO RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD LUER LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO.·Product code FMF·November 7, 2014
UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·September 9, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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