9 results
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21ms
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Sources: EU EUDAMED, US FDA
Klär Lite (RCW-KL1000)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ennovate Cervical Spinal and Occiput System
FDA 510(k)
FDA Class 2
·Orthopedic
Miria Skin Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
BD MICRO-FINE¿+ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 19, 2022
COGNIS HE IS-1/DF-1/IS-1
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 11, 2011
M2A 38MM MODULAR HEAD+6MM NK NO SKRT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·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