9 results
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19ms
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Sources: EU EUDAMED, US FDA
Outlook Surgical Versa One System (8900139)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TRIAL INSERT D.60 REPLACE CUP HOLDERS
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489417313·
NEPHROS DSU-H, NEPHROS SSU-H
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Diode Laser Body Sculpture System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PEN NDL 31G 5MM 100CT GR NO PT ROCHE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code NSC·March 21, 2019
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 10, 2014
DUROM US ACETABULAR COMPONENT 50/44 J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·November 24, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
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