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

VIVOSIGHT TOPICAL OCT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VITROS Immunodiagnostic Products Syphilis Reagent Pack

FDA 510(k)

FDA Class 2 ·Microbiology

TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Genex Bone Graft Substitute

FDA 510(k)

FDA Class 2 ·Orthopedic

Solas OR

FDA 510(k)

FDA Class 2 ·Radiology

Venus Silk.expert

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ultravision™ Visual Field Clearing System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TAMPON, UNTREATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology