BUN REAGENT ASTRA 4 & 8 ANALYZERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUICKSTART UREA NITROGEN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-LA (SS-B)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-RO (SS-A)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-SM

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ENA PROFILE

FDA 510(k)

FDA Class 2 ·Immunology

UNIPULSE CO2 SURGICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Ceevra Reveal 3+

FDA 510(k)

FDA Class 2 ·Radiology

A.R.M. (ASPEN RETURN MONITOR)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device (BE965A, BE965B, BE965C)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00

FDA 510(k)

FDA Class 2 ·General Hospital

MALDI Biotyper CA System

FDA 510(k)

FDA Class 2 ·Microbiology

TM eCloud ECG Analysis System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Abiomed 14Fr Low Profile Introducer Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

SelectFlex Neurovascular Access System Family

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000

FDA 510(k)

FDA Class 2 ·Ophthalmic

NIDEK CV-12000

FDA 510(k)

FDA Class 2 ·Ophthalmic

ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES

FDA 510(k)

FDA Class 2 ·Radiology