13 results
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22ms
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Sources: EU EUDAMED, US FDA
Fluoride Varnish (Type A,Type C)
FDA 510(k)
FDA Class 2
·Dental
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011253052200·ceraMotion® Lf Dentin C3, 20 g / dental ceramic...
MEDELA SWING BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Erchonia PL Touch
FDA 510(k)
FDA Class 2
·Physical Medicine
M/DN®
FDA UDI
Zimmer, Inc.·00889024043213·
ITST®
FDA UDI
Zimmer, Inc.·00889024043237·
M/DN®
FDA UDI
Zimmer, Inc.·00889024043220·
M/DN®
FDA UDI
Zimmer, Inc.·00889024043244·
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 4, 2008
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE CANADA LTD.·Product code MMI·August 31, 2011
MINILINK TRANSMITTER
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 29, 2013
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·June 10, 2015
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