9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR
FDA 510(k)
FDA Class 1
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450141045·
HARDYDISK, CEPHALOTHIN 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO THE GRIP
FDA 510(k)
FDA Class 2
·Cardiovascular
ALTO 2
FDA Adverse Event
Injury
·ELA MEDICAL, S.A.S.·Product code MRM·July 11, 2006
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2013
FLAIR ENDOVASCULAR STENT GRAFT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code MIH·March 15, 2011
TENDRIL DX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 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