9 results
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20ms
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Sources: EU EUDAMED, US FDA
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k)
FDA Class 2
·Neurology
KLOCKNER VEGA DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OPTIUM DBM GEL AND PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 28, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·December 5, 2008
UNKNOWN DEPUY ARTICULEZE 32MM +1 HEAD
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code JDI·September 19, 2011
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code HDD·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