13 results
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19ms
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Sources: EU EUDAMED, US FDA
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Armada
FDA UDI
Nuvasive, Inc.·00887517223005·ARM15T Screw, 4x25mm PLS
MORRISON MEDICAL
FDA UDI
MORRISON MEDICAL, LTD·00647921254022·CORR.PLSTC.SPLNT.24"CTR.FM./25
Phantom
FDA UDI
Innovative Med·00851314007038·Surgical Aspirator:1/3 hp. 0-3.6 scfm / 0-27.5 ...
NA
FDA UDI
Exactech, Inc.·10885862525420·TRIAL, TIBIAL ADAPTOR, PLATE, SIZE 2.5
PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
22.2mm BIOLOX® delta Ceramic V40 Femoral Heads
FDA 510(k)
FDA Class 2
·Orthopedic
BD PLATE MAC CONKEY II AGAR 90MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·February 28, 2022
ENDOWRIST SMALL CLIP APPLIER (DA VINCI)
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL·Product code NAY·June 26, 2013
IMPLANTABLE CHF GENERATOR
FDA Adverse Event
Product code NIK·November 11, 2008
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY - SAN JOSE·Product code FCW·August 11, 2011
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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