13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Valeo Spacer System and Valeo II Interbody Fusion Device System
FDA 510(k)
FDA Class 2
·Orthopedic
VALEO / VALEO II
FDA Adverse Event
Malfunction
·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828188494·GEN4 INTERACTIVE
LEONE SPA
FDA UDI
LEONE SPA·08033707012146·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL18
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376695259·PROXIMITY FA SELF-DRILL SCREW, 3.5 x 18mm
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376546087·SPS FA Self-Drill Screw, 3.5 x 18 mm
Complete Cervical
FDA UDI
Seaspine Orthopedics Corporation·10889981041069·Screw - Self-Drilling - 3.5x18mm
TRINITY ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RADIOPAQUE BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 3, 2013
MOBI-C CERVICAL DISC PROSTHESIS
FDA Adverse Event
Injury
·LDR MEDICAL·Product code MJO·September 4, 2014
GPS PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·June 2, 2011
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026