10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Fetal Doppler, Model FD88
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011827100·A Masking, Red-Brown
Symetri Clear
FDA UDI
ORMCO CORPORATION·00889989084719·L5R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI...
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1
NEO-SERVO I
FDA 510(k)
FDA Class 2
·General Hospital
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 8, 2011
VAPR S90 ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code GEI·September 25, 2008
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