11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Light Cure Adhesive
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Zimmer, Inc.·00889024062283·
2.0/2.4MM FRACTURE SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036035969·
Portex
FDA UDI
ICU MEDICAL, INC.·15019517082982·
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
FDA 510(k)
FDA Class 2
·General Hospital
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·August 1, 2019
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 21, 2008
UNKNOWN DEPUY ASR HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·September 9, 2011
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 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