10 results
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19ms
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Sources: EU EUDAMED, US FDA
Pixie Pulse (SM9068)
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517631251·CoRoent Ant TLIF Ti, 14x11x36mm 15°
J & J INSTRUMENTS
FDA UDI
J & J INSTRUMENTS INC·00817524026184·ROCHESTER PEAN 8" CVD
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
True 3D Viewer
FDA 510(k)
FDA Class 2
·Radiology
IMP,TSV,4.7,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 24, 2021
ENDO STITCH* 10MM SUTURING DEVICE
FDA Adverse Event
Malfunction
·COVIDIEN·Product code KOG·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 22, 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