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

ULTIMA SNORING MIKE, MODEL 0540

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

FDA 510(k)

FDA Class 2 ·Dental

MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC

FDA 510(k)

FDA Class 2 ·Dental

Hemodialyzer With Expanded Solute Removal Profile

FDA classification

FDA Class 2 ·Hemodialyzer With Expanded Solute Removal Profile

Anti-Factor Xa Activity Test System, Apixaban

FDA classification

FDA Class 2 ·Anti-Factor Xa Activity Test System, Apixaban

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SAHARA CLINICAL BONE SONOMETER