9 results
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20ms
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Sources: EU EUDAMED, US FDA
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
FDA 510(k)
FDA Class 2
·Immunology
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
Standard Clamp
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·August 3, 2011
PUMP MMT-722RNAL PRDGM INS CL EN RC
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·December 2, 2008
MEGA NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 29, 2013
ANGIODYNAMICS
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code OEZ·February 21, 2018
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