Uroject12 Syringe Lever

FDA 510(k)

FDA Class 2 ·General Hospital

CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1

FDA 510(k)

FDA Class 2 ·Neurology

HYBRID ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays

FDA 510(k)

FDA Class 2 ·Orthopedic

Equinoxe® Central Screw Baseplate System

FDA 510(k)

FDA Class 2 ·Orthopedic

IDC INTERLOCKING DETACHABLE COIL

FDA 510(k)

FDA Class 2 ·Cardiovascular

Uroject12 Syringe Lever

FDA 510(k)

FDA Class 2 ·General Hospital

Vantage® Total Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

Exactech® TRULIANT® Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3

FDA 510(k)

FDA Class 2 ·Physical Medicine

Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

REMOTE VIEW SOFTWARE

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