Personal Kinetigraph (PKG) System Gen 2 Plus

FDA 510(k)

FDA Class 2 ·Neurology

PERSONAL KINETIGRAPH (PKG) SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Personal Kinetigraph (PKG) System

FDA 510(k)

FDA Class 2 ·Neurology

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EKP-i5010 Video Processor with EB Family

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·RESOLVE/GP(TM) DAILY CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·RESOLVE/GP(TM) DAILY CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·RESOLVE/GP(TM) DAILY CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·RESOLVE/GP(TM) DAILY CLEANER

HM70 EVO Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·COMFORTCARE GP(R) WETTING AND SOAKING SOLUTION

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE (Colors & Flavors), SKORE (Colors)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IN VITRO PHENOBARBITAL RIA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FLUOROMATIC PHENOLBARBITAL FIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA