10 results
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37ms
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Sources: EU EUDAMED, US FDA
Velmeni for Dentists (V4D) Endo-Perio
FDA 510(k)
FDA Class 2
·Radiology
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUVANCE* FACIAL REJUVENATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 30, 2023
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 11, 2023
ACUVUE OASYS BRAND CONTACT LENS
FDA Adverse Event
VISTAKON·Product code LPL·November 12, 2014
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
8CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 29, 2013
CRIT-LINE BLOOD CHAMBER
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KOC·July 21, 2018
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