8 results
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19ms
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Sources: EU EUDAMED, US FDA
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
FDA 510(k)
FDA Class 1
·General Hospital
M3046B COMPACT PORTABLE PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
IMP,TSV,6.0,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 8, 2022
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·December 2, 2008
MBT CEM KEEL TIB TRAY SZ5
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code NJL·September 19, 2011
BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·July 15, 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