58 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LARGE CANNULATED SCREWS
FDA UDI
Smith & Nephew, Inc.·03596010063953·6.5MM UNIVERSAL CANNULATED SCREW 100MM
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1216400·12m H x 16mm W x 40mm L x 0 degrees XLIF
Phantom® Fibula Nail System
FDA UDI
Paragon 28, Inc.·00889795146229·1.6mm x 400mm, Entry Guidewire, Trocar
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L121640120·12mm H x 16mm W x 40mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X12164080·12mm H x 16mm W x 40mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X121640120·12mm H x 16mm W x 40mm L x 12 degrees XLIF
HANSATOME EXCELLUS MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PRECISION FLOW(R) - HELIOX
FDA 510(k)
FDA Class 2
·Anesthesiology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 4, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 4, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 31, 2019
PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 14, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 30, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 30, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·March 2, 2021
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·March 2, 2021
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·November 10, 2017