Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITS C CHECK TEST SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SERVICE

WiZARD 520 Full Face Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

NaviCam ProScan

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Radiofrequency Generator System, Cura RF Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS

FDA 510(k)

FDA Class 2 ·General Hospital

SIRIUS Endoscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bone Marrow Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Reusable & Disposable SpO2 Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOMED Mesh Nebulizer

FDA 510(k)

FDA Class 2 ·Anesthesiology

Electrical Neuromuscular Stimulator, Cure Trio

FDA 510(k)

FDA Class 2 ·Neurology

Electrode Pad

FDA 510(k)

FDA Class 2 ·Neurology

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM