INSTINCT JAVA SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DYNESYS TOP-LOADING SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SANARUS VISICA TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GripMate

FDA 510(k)

FDA Class 2 ·General Hospital

Shapiro MD model laser 272

FDA 510(k)

FDA Class 2 ·Physical Medicine

SANARUS INDICA MARKER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SANARUS VISICA TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NI-PACER 1

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL EB-22 NOISE STIK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ARMSTRONG STERILE SALINE SOLUTION

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-SLA/LP ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

StimQ Peripheral Nerve Stimulator (PNS) System

FDA 510(k)

FDA Class 2 ·Neurology

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder

FDA 510(k)

FDA Class 2 ·Dental

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology