VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME

FDA 510(k)

FDA Class 2 ·Immunology

OPTYSE OPHTHALMOSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

INTEGRITY, MODEL V500

FDA 510(k)

FDA Class 2 ·Neurology

THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arm-type Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Forehead Thermometer, Model BSX976

FDA 510(k)

FDA Class 2 ·General Hospital

WELLCOGEN BACTERIAL ANTIGEN KIT

FDA 510(k)

FDA Class 2 ·Microbiology

FREEDOM CONSTRAINED LINERS

FDA 510(k)

FDA Class 2 ·Orthopedic

WILLCOGEN MENINGITIDIS KIT ZL25

FDA 510(k)

FDA Class 2 ·Microbiology

35/CD CINECONVERTER

FDA 510(k)

FDA Class 2 ·Radiology

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51

FDA 510(k)

FDA Class 2 ·Microbiology

WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

FDA 510(k)

FDA Class 2 ·Microbiology

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ANI BIOCARD HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry