SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS

FDA 510(k)

FDA Class 2 ·Hematology

TOP WHOLESOME FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FORTUNE SILICONE VACUUM SUCTION, MODEL #1300

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38

FDA 510(k)

FDA Class 2 ·Ophthalmic

EOS PMP, EOS PMP Integrated

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERFORMER HT/ HANG&GO HT BASIC

FDA 510(k)

FDA Class 2 ·General Hospital

AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control

FDA 510(k)

FDA Class 2 ·Ophthalmic

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

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

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) AMPICILLIN/SULBACTAM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·NOR-SA-TAB