ALMOST U, INC. BREAST PROSTHESIS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

BUFFALO FILTER VIROSAFE HRF- #VSHRFO1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PR-3 ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

SMOKE EVACUATION ATTACHMENT 130XXX TBD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AC/AD LINEARITY VERIFIERS

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RIO EYEWEAR, PANAMA JACK ENVIRONMENT OPTICS, AND PARADISE RESORT EYEWEAR

FDA 510(k)

FDA Class 1 ·Ophthalmic

BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IBC VENT VALVE, MODEL 1400

FDA 510(k)

FDA Class 2 ·Cardiovascular

EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET

FDA 510(k)

FDA Class 2 ·Hematology

SEARE BIOMEDICAL MALAR IMPLANTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

URIC ACID (LIQUID) REAGENT SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SEARE BIOMEDICAL SILICONE BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAX IT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology