9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROSTHESIS, RICHARDS MOD II KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110621·COAXIAL VISCOELASTIC ASPIRAT-IRRIGAT TIP
Visco (olifilcon A) soft contact lens
FDA 510(k)
FDA Class 2
·Ophthalmic
HARMONIC SCALPEL BLADES AND SHEARS
FDA 510(k)
FDA Unclassified
·Unknown
SHUNT CENTRAL NERVOUS SYSTEM AND COMPS
FDA Adverse Event
Injury
·Product code JXG·April 19, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 26, 2012
CE INFUSOR LV 5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 16, 2010
ONYX AVM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·June 24, 2019
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014