12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Medicell Mycosis Laser (MCML24004)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INNOVERSE Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
LiverMultiScan v5 (LMSv5)
FDA 510(k)
FDA Class 2
·Radiology
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 27, 2023
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 27, 2023
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 27, 2023
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 27, 2023
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 24, 2025
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 11, 2011
ASPHERE M SPEC 11/13 44 +6
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·July 30, 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