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

Disposable ureteral access sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable General Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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.

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Arthroscopic Electrode (with Pencil)

FDA 510(k)

FDA Class 2 ·Orthopedic

Thin Layer Chromatography, Ethosuximide

FDA classification

FDA Class 2 ·Thin Layer Chromatography, Ethosuximide

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anit-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE BLAIREX SYSTEM