Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SERVICE

SURGICAL LIGHTING-CENTRA 450

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DELSONIC 2000

FDA 510(k)

FDA Class 2 ·Dental

JETSONIC 2000

FDA 510(k)

FDA Class 2 ·Dental

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Autoclave Indicator Tape; EO Indicator Tape

FDA 510(k)

FDA Class 2 ·General Hospital

SPY Elite Intraoperative Perfusion Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PINPOINT Endoscopic Fluorescence Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPY-PHI System with SPY-PHI Fluorescence Assessment Software

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PressureWire X

FDA 510(k)

FDA Class 2 ·Cardiovascular

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

FDA 510(k)

FDA Class 2 ·Hematology

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORIN BIPOLAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-OSS COLLAGEN

FDA 510(k)

FDA Class 2 ·Dental

JO-1 EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

PFF-1

FDA 510(k)

FDA Class 2 ·Anesthesiology