10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK
FDA 510(k)
FDA Class 2
·Dental
LCP
FDA UDI
Synthes GmbH·10886982165923·3.5MM LCP T-PLATE 3H HEAD/ 3H SHAFT/50MM-RIGHT ...
TOTAL MANDIBULAR SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036062552·
TIGHTRAIL MINI
FDA 510(k)
FDA Class 2
·Cardiovascular
APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
QUANTUM? MAVERICK?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·November 10, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 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