11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smartxide Tetra Pro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safecare Vinyl Exam Gloves
FDA UDI
ARISE MEDICAL LLC·00372217036104·Safecare Vinyl Exam Gloves - XL- 100 Ct
ECVUE MAPPING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DISTAL RADIO-ULNAR JOINT IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·July 15, 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