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FDA 510(k)

FDA Class 2 ·General Hospital

LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

FDA 510(k)

FDA Class 2 ·Immunology

UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

FDA 510(k)

FDA Class 2 ·Immunology

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

LIPIDURE REWETTING DROPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

BRYAN SPINAL FIXATER (BSF)

FDA 510(k)

FDA Class 2 ·Orthopedic

ALTACARE

FDA 510(k)

FDA Class 2 ·General Hospital

CTF MODEL 9300

FDA 510(k)

FDA Class 2 ·Radiology

Duet External Drainage and Monitoring System (EDMS)

FDA 510(k)

FDA Class 2 ·Neurology

Medtronic DUET External Drainage and Monitoring System

FDA 510(k)

FDA Class 2 ·Neurology

DEEPVISON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BUFFERED AEROSOL SALINE SOLUTION (BL-2700-NS9)

Q-Switched Nd:Yag laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AVC A/H5N1 FLU TEST

FDA 510(k)

FDA Class 2 ·Microbiology

REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE

FDA 510(k)

FDA Class 2 ·Orthopedic

Signature Osteosynthesis Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

360CAS

FDA 510(k)

FDA Class 2 ·Neurology

X-Y Lubricating Jelly

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LAITEST Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery