9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QSC-127-INT SHOULDER ARRAY COIL SET
FDA 510(k)
FDA Class 2
·Radiology
DENTSPLY INDUSTRIA E COMERCIO LTDA
FDA registration
DENTSPLY INDUSTRIA E COMERCIO LTDA·2 products·🇧🇷 Brazil
ANEUVYSION MULITICOLOR DNA PROBE KIT
FDA 510(k)
FDA Class 2
·Immunology
REICHERT CT200 CONTACT TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·April 8, 2013
PENTA 3MM LEAD, 60 CM
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 15, 2011
ICM (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL·Product code MTA·May 8, 2008
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 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. 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