11 results
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25ms
·
Sources: EU EUDAMED, US FDA
KODAK EKTACHEM DTSC II SLIDES (LI)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SwishTapered™ Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106388·4.1mmD x 6mmL, 4.8mmD Platform
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150737·K-WIRE - SINGLE TROCAR 1.0mm DIA x 150mm
Venue Fit
FDA 510(k)
FDA Class 2
·Radiology
INTRAVENOUS INFUSION CONTROLLER
FDA 510(k)
FDA Class 2
·General Hospital
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·September 9, 2013
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·September 9, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL- NEUROMODULATION DIVISION·Product code LGW·December 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 3, 2014
DRILL, TRI-FLAT T2 FEMUR 4,2X340MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 19, 2012
SwishTapered Implant Intended for use in support for fixed bridgework.
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·March 28, 2018