IMMULITE/IMMULITE® 1000 Cortisol

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SIGMA ALPHA VAPORIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT

FDA 510(k)

FDA Class 2 ·Immunology

OLYMPUS SUCTION PUMP, MODEL KV-5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PORTEX PERCUTANEOUS TRACHEOSTOMY KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIASTAT ANTI-PR3 (C-ANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

SIMPLA S4, S5, S7

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SHAH PERMAVENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMERLITE MAB FT4 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTOSTAT II ANTI-SM/RNP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

P200TE (A10700)

FDA 510(k)

FDA Class 2 ·Ophthalmic

BENCHMARK TRANSFER TEST

FDA 510(k)

FDA Class 2 ·Anesthesiology

PROLONG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology