8 results
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21ms
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Sources: EU EUDAMED, US FDA
Helo Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILE BLUE POWDER FREE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
Pulp Canal Sealer, Pulp Canal Sealer EWT
FDA 510(k)
FDA Class 2
·Dental
PERSONA STEMMED CEMENTED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·November 12, 2014
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·September 9, 2011
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 29, 2013
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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