Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL FAMILIES

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BIOLON 1% SODIUM HYALURONATE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL RF HEART FAILURE PULSE GENERATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM FAMILY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MRICS AND LZ OCTAD LEAD FAMILIES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Sculptra

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·Model 203 Life Pulse High Frequency Ventilator

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

FDA 510(k)

FDA Class 3 ·Cardiovascular

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·PerClot Polysaccharide Hemostatic System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE (LN 6L22)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·Optiguide Cylindrical Fiber Optic

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB, Alinity i Anti-HBs

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS