ALLERG*ENS ENZYME IMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

NOVAKONE SPHERICAL AND TORIC LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS

FDA 510(k)

FDA Class 2 ·Orthopedic

Shaders ZR

FDA 510(k)

FDA Class 2 ·Dental

ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDICAL LABS FETAL SCAN #1000 W/CENTRAL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ALKALINE PHOSPHATASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INVIVO PULSE OXIMETER, MODEL 4500

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GOAT ANTI-RUBELLA ANTISERA

FDA 510(k)

FDA Class 2 ·Microbiology

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LACTATE DEHYDROGENASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIGIT WIDGET

FDA 510(k)

FDA Class 2 ·Orthopedic

ALBUMIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE

FDA 510(k)

FDA Class 2 ·Orthopedic

GOLDEN MEAN MACHINE(TM) (CLASS 2)

FDA 510(k)

FDA Class 2 ·Physical Medicine

COMPLETE DENTURE REPAIR KIT

FDA 510(k)

FDA Class 2 ·Dental

AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)

FDA 510(k)

FDA Class 2 ·Ophthalmic

TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry