DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DISTALOCK TIBIAL IM NAIL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX

FDA 510(k)

FDA Class 2 ·Orthopedic

DRIVE RAIL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

XTERN FOOT DROP ORTHOTICS - PLASTIC PARTS REPLACEMENT

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·20 devices

XTERN SOFT PARTS - REPLACEMENT PARTS

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·7 devices

XTERN OPTIONS

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·5 devices

AT-X ASSESSMENT TOOL (CLINICAL TRIAL ADJUSTABLE ORTHOTIC)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·2 devices

XTERN FRONTIER ANTERIOR FOOT DROP ORTHOTIC

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·3 devices

XTERN CLASSIC FOOT DROP ORTHOTIC

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·1 device

XTERN SUMMIT FOOT DROP ORTHOTIC

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·3 devices

XTERN CLASSIC+ FOOT DROP ORTHOTIC

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Turbomed Orthotics inc.·3 devices

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS ANTI-HCV