11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
"2.0/2.4MM" FRACTURE SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036036171·
STA LIATEST D-DI
FDA 510(k)
FDA Class 2
·Hematology
RANDOX OPIATES ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
AMPLATZER PFO OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·March 10, 2020
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG NON US
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·November 19, 2008
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
HEARTMATE II LVAS
FDA Adverse Event
THORATEC CORPORATION·Product code DSQ·July 22, 2013
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011
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