9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRADIA DIRECT LOFLO
FDA 510(k)
FDA Class 2
·Dental
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809872538·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
FDA 510(k)
FDA Class 2
·Anesthesiology
MAXIM RPG PS FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 20, 2025
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·February 15, 2011
CONTAK RENEWAL 3 RF HE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013