10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Momcozy Wearable Breast Pump (BP311)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LCP
FDA UDI
Synthes GmbH·10886982167460·2.4MM LCP® RADIAL HEAD RIM PLATE 2 HOLES-RIGHT
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws
FDA 510(k)
FDA Class 2
·Orthopedic
ORAJEL ADVANCED TOOTH DESENSITIZER
FDA 510(k)
FDA Class 2
·Dental
IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 26, 2024
IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 22, 2022
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 19, 2008
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 9, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·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