9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIBA CORNING ACS TSH IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756389648·CYSTO PACK
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981080280·5.0 mm Trial Rod Silicone Covered
NEX-D2 Posterior Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
GSA GENITO SENSORY ANALYZER
FDA 510(k)
FDA Class 1
·Neurology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 11, 2013
HUIBREGTSE SINGLE LUMEN NEEDLE KNIFE
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·November 23, 2010
ATLAS PLUS VR
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024