Phenom Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

React 71 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892

FDA 510(k)

FDA Class 2 ·Neurology

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Mico One Orthodontic Screw

FDA 510(k)

FDA Class 2 ·Dental

Rapid Barostat Bag (RBB) Pump and Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SilverCoat Silicone Foley Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PatCom Distal Chip Endoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Garment Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

Conductive Gel

FDA 510(k)

FDA Class 2 ·Neurology

TONE-A-MATIC

FDA 510(k)

FDA Class 2 ·Physical Medicine

PatCom Single-Use Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRESSURIZED INFUSION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HD-4 CROWN & BRIDGE ALLOY

FDA 510(k)

FDA Class 2 ·Dental

SERUM TRANSPORT VIALS, T25/SC, TZ10/SC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV (LN 1L79)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV (LN 5C36)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV (LN 5C36)