9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Youlaser CO2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIODE LASER THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TATTOOSTAR EFFECT Y
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·October 3, 2008
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·July 28, 2011
6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code NKB·June 21, 2013
MOBILETT ELARA MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014