QUICKVUE ONE-STEP HCG-COMBO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Fractional CO2 Laser Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Picosecond ND: YAG Laser System (PZ-6)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

AIC disposable medical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DCM Kyphoplasty System

FDA 510(k)

FDA Class 2 ·Orthopedic

Disposable Laryngeal Electrodes

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARDIOMET 4000 GAS MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BC-3600 Auto Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Muscle Stimulator Device (PZ-100)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Ureterorenoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC MONORAIL/NC BIG RANGER/NC RANGER PTCA CATHETHERS

ECOMA Level 2 Disposable Surgical Mask with Ear Loops

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pulse Oximeter ( PO2, PO2A, PO2B)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZS3 and z.one pro Ultrasound Systems

FDA 510(k)

FDA Class 2 ·Radiology