9 results
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23ms
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Sources: EU EUDAMED, US FDA
Percutaneous Endoscopic Gastrostomy (PEG) Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199427·Revision Knee Spiral Reamer- Hudson Long Flutes...
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106556·ADSON TISSUE FORCEPS 1X2 TEETH DELICATE
PHAROS
FDA 510(k)
FDA Class 2
·Radiology
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Y CONNECTOR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTD·November 11, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 19, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·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