14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMSCO EVOLUTION MEDIUM STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740824350·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674082435060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0824350·8mm H x 24mm W x 35mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X082435120·8mm H x 24mm W x 35mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L082435120·8mm H x 24mm W x 35mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08243580·8mm H x 24mm W x 35mm L x 8 degrees XLIF
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 19, 2019
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
FDA 510(k)
FDA Class 1
·Ophthalmic
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CRYSTALENS ACCOMMODATING IOL
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·April 24, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·May 10, 2011
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LP (US SURGICAL)·Product code GEI·July 21, 2008
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015