38 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0100220·Caddie, Rods, Adjustable Cross Links, and Caps
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100120·Counter Torque, Offset
Ocata Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07308K0100020·Caddie, Screws
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100020·Impactor Head, Modular, InTess C
Matira
FDA UDI
Kalitec Direct LLC·B07307K0100220·Assembly, Caddie, 1-3L Plates, Hnged
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100020·Tap, 4.5mm Cann, Quarter Square
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0100020·Caddie, 1-3 Level Plates
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100220·SNII Awl Tap, 6.50mm
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
FDA 510(k)
FDA Class 1
·Radiology
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
FDA 510(k)
FDA Class 2
·Radiology
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000 XPI ANTI-HBS
POLARIS ULTRA
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FAD·June 27, 2019
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ANTI-HBS IMMULITE SUBSTRATE REAGENT
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ANTI-HBS IMMULITE ASSAY
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE® 2000 Anti-HBs
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·IMMULITE 2000 Anti-HBs