ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling

FDA 510(k)

FDA Class 2 ·Orthopedic

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

FDA 510(k)

FDA Class 2 ·Hematology

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Erythropoietin (EPO) assay

FDA 510(k)

FDA Class 2 ·Hematology

ARCHITECT Active-B12 (Holotranscobalamin)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

FDA 510(k)

FDA Class 2 ·Immunology

BERA SH 221 BRIAN STEM AUDIOMETER

FDA 510(k)

FDA Class 1 ·Microbiology

SYNOTEX MASK (White)

FDA registration

SYNOPEX BIOFILTER·1 product·🇰🇷 South Korea

Hot-detox Foot Heating Care Solution

FDA registration

VIGOR HEALTHCAREPLUS·1 product·🇰🇷 South Korea

Absolute Water Purifier(MAX)(Black)

FDA registration

SYNOPEX BIOFILTER·1 product·🇰🇷 South Korea

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·Artegraft Collagen Vascular Graft

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·Artegraft Collagen Vascular Graft

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·N.C.G.T. GRAFT