qER

FDA 510(k)

FDA Class 2 ·Radiology

ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI

FDA 510(k)

FDA Class 2 ·Dental

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

truSculpt flex

FDA 510(k)

FDA Class 2 ·Physical Medicine

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

Pitkar Locked Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

STAR 90

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

FDA classification

FDA Class 2 ·Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

Gas Chromatography, Cocaine

FDA classification

FDA Class 2 ·Gas Chromatography, Cocaine

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

FDA classification

FDA Class 2 ·Tyrosine Phosphatase (Ia-2) Autoantibody Assay

Dengue Nucleic Acid Amplification Assay (Naat)

FDA classification

FDA Class 2 ·Dengue Nucleic Acid Amplification Assay (Naat)

Kit, Conception-Assist, Home Use

FDA classification

FDA Class 2 ·Kit, Conception-Assist, Home Use

Aquaporin-4 Autoantibody

FDA classification

FDA Class 2 ·Aquaporin-4 Autoantibody

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Sars-Cov-2 Serology Test

FDA classification

FDA Class 2 ·Sars-Cov-2 Serology Test

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope