Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact Spine Sealant System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus® Microstent

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO, MODEL 2603

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO, MODEL 2502

FDA 510(k)

FDA Class 3 ·Cardiovascular

DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO MODEL #2516

FDA 510(k)

FDA Class 3 ·Cardiovascular

DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P

FDA 510(k)

FDA Class 3 ·Cardiovascular

SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA

FDA 510(k)

FDA Class 3 ·Cardiovascular

DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS

FDA 510(k)

FDA Class 3 ·Cardiovascular

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion® Indirect Decompression System