10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KOWA GENESIS-D HAND-HELD RETINAL CAMERA
FDA 510(k)
FDA Class 2
·Ophthalmic
PULSE
FDA UDI
Nuvasive, Inc.·00195377051509·PULSE 1/4 Square Drill Bit, 4.0mm
THINKINGNET
FDA 510(k)
FDA Class 2
·Radiology
HARDYDISK, SULFA/TRIMETH
FDA 510(k)
FDA Class 2
·Microbiology
RECOVERY FILTER
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 18, 2020
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GDO·April 5, 2013
PUMP MMT-515LNAP PRDGM INS V2.1 PL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·May 22, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 12, 2011
RECOVERY FILTER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·April 17, 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