10 results
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18ms
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Sources: EU EUDAMED, US FDA
Orca Air/Water and Suction Valves
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106396·GIRARD FORCEPS 0.12MM LEFT
Buxton BioMedical
FDA UDI
Buxton Biomedical Inc·B768742529100·Buxton Hemi Retr,R,100x10mm
NA
FDA UDI
Exactech, Inc.·10885862552440·TIBIAL SHIM, SZ 5/6 10 MM
POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
FDA 510(k)
FDA Class 1
·Dental
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
PERSONA PEGGED POROUS TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code OIY·November 12, 2014
UNKNOWN DBS LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·July 29, 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