11 results
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19ms
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Sources: EU EUDAMED, US FDA
Glucommander
FDA 510(k)
FDA Class 2
·Anesthesiology
LANDANGER
FDA UDI
LANDANGER·03661219331872·
BD BBL™ CHROMagar™ Orientation Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902541025·BD BBL™ CHROMagar™ Orientation Agar
Phantom
FDA UDI
Innovative Med·00851314007038·Surgical Aspirator:1/3 hp. 0-3.6 scfm / 0-27.5 ...
Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)
FDA 510(k)
FDA Class 2
·Cardiovascular
Glidewell Appliance Resin, Hard/Soft
FDA 510(k)
FDA Unclassified
·Unknown
CONTAK RENEWAL 2
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 19, 2011
DXTEND SCREW NO LOCK D4.5X30MM
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code HSD·July 30, 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
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026