STRYKER CEMENT REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PROSTHETIC CEMENT REMOVER

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTOMATED ENDOSCOPE LEAK TESTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Piccolo Potassium Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR

FDA 510(k)

FDA Class 2 ·Orthopedic

ACRYL-X II SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)

FDA 510(k)

FDA Class 2 ·Microbiology

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

FDA 510(k)

FDA Class 2 ·Microbiology

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Solana HSV 1+2/VZV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m HSV 1 & 2 / VZV

FDA 510(k)

FDA Class 2 ·Microbiology

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

HIGH SPEED EMG MODULE

FDA 510(k)

FDA Class 2 ·Neurology

OHMEGA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MMS VIDEO OPTION

FDA 510(k)

FDA Class 2 ·Radiology

SOLAR GI SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology