12 results
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26ms
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Sources: EU EUDAMED, US FDA
ORTHOMET BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916493287·Multi-Axial Fenestrated Screw, Ø5.0 x 50mm, Ø6....
Centerline Cannulated Accessories
FDA UDI
Life Spine, Inc.·00190837021108·
G-Beam Fusion Beaming System
FDA UDI
ORTHOFIX SRL·18053504360469·G-BEAM STAINLESS STEEL FUSION BEAM L50MM D5.4MM...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668109526·BISHOP-HARMON IRRIGATING CANNULA 19GA
Arthrex®
FDA UDI
ARTHREX, INC.·00888867524002·Spine Compression Screw, 5.0x50mm
STORZ E9040 & E9046 DIAMOND KNIVES
FDA 510(k)
FDA Class 1
·Ophthalmic
UP800 A UNIVERSAL PRINTER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 16, 2014
CE INTERMATE LV 100, 24 PACK,50126
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - DEERFIELD·Product code FRN·October 19, 2010
LAMITRODE 4
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 12, 2012
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 4, 2020