10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
NEUROPROBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GC Initial™
FDA UDI
Gc America Inc.·J0228740181·GC Initial™ Ti Powder Opaque Mod. OM-2, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556704742·GC Initial™ AL Liner Lin-6 D2/D3/D4, 20g
Arthrex®
FDA UDI
ARTHREX, INC.·00888867523647·Spine Compression Screw, 4.0x18mm
GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAMPY MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 21, 2014
THINLINE
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 19, 2010
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 14, 2012
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 25, 2015