CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Geneo X Elite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReDs Wearable System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEERSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PillCam Patency System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BOBCAT DX

FDA 510(k)

FDA Class 2 ·Physical Medicine

ReWalk P6.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NOGA

FDA 510(k)

FDA Class 2 ·Cardiovascular

PillCam COLON 2 Capsule Endoscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

FDA classification

FDA Class 2 ·Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

STRATUS CS D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

NIR BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NIR BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DADE THROMBIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)

FDA 510(k)

FDA Class 2 ·Immunology