52 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Omnipod DASH Insulin Management System
FDA 510(k)
FDA Class 2
·General Hospital
Sterilizable Handle for DoVera DE12 Examination Light Series
FDA UDI
SKYTRON LLC·10841736123536·DE12 Sterilizable Handle
FINN KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304268906·
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981169060·CORTICAL SHANK, Cannulated, 8.0 X 45
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987169064·CORTICAL SHANK, Cannulated, 8.0 X 45
SSW Carbide Fissurotomy
FDA UDI
Ss White Burs, Inc.·D6901800452·FG CLF- 5 PACK
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009566·PedFuse Reset, CNL, 6.0mm x 40mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009597·PedFuse Reset, CNL, 6.0mm x 55mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009559·PedFuse Reset, CNL, 6.0mm x 35mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009580·PedFuse Reset, CNL, 6.0mm x 50mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009573·PedFuse Reset, CNL, 6.0mm x 45mm
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009542·PedFuse Reset, CNL, 6.0mm x 30mm
Sochi
FDA UDI
Altus Spine, LLC·00843210173801·Rod, 3.5mm x 45mm
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981028862·Straight Rod 5.5 x 45
OCTO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Distraction Paddle - 13mm
FDA UDI
CAPTIVA SPINE, INC.·00850065741680·Distraction Paddle - 13mm
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023