38 results · 24ms · Sources: EU EUDAMED, 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