illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10

FDA 510(k)

FDA Class 2 ·Microbiology

POWERDRIVE 350 OPTION

FDA 510(k)

FDA Class 2 ·Radiology

Xspan Laminoplasty Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

MIM – Additional Tracers

FDA 510(k)

FDA Class 2 ·Radiology

DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TETRIS II

FDA 510(k)

FDA Class 2 ·Orthopedic

Type 5 Integrating Indicator for Steam (CSPN-15)

FDA 510(k)

FDA Class 2 ·General Hospital

MERIT

FDA 510(k)

FDA Class 2 ·Radiology

IV ADMINISTRATION SET FPA

FDA 510(k)

FDA Class 2 ·General Hospital

AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS

FDA 510(k)

FDA Class 2 ·Radiology

EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS

FDA 510(k)

FDA Class 2 ·Radiology

AIRIS ELITE RAPID BODY COIL

FDA 510(k)

FDA Class 2 ·Radiology

PHARMACOKINETICS SOFTWARE SYSTEM (PPS)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SNJ SMOKE EVACUATION SUCTION WAND

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES

FDA 510(k)

FDA Class 2 ·Anesthesiology