11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
FDA 510(k)
FDA Class 2
·Orthopedic
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994305152·IMPLANT 6240441 ANATOMIC 14X11X14MM
ANATOMIC PEEK CERVICAL FUSION SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994360564·IMPLANT 4240441 ANATOMIC C 14X11X 14MM
BI-FLEX URETERAL ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UroLift Advanced Tissue Control (ATC) System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
*
FDA Adverse Event
Other
·*·Product code BTG·August 14, 2008
2MM COARST DIAMOND BALL, STD
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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