Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Lead

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, CP, and CP with SmartAssist

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·Fluency® Plus Endovascular Stent Graft

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT TB TEST

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY FAMILY OF ICDS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APS III PROGRAMMER WITH MODEL 3303 SOFTWARE

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBC IGM EIA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS, REVEAL PLUS & BOSS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL FAMILIES OF LEADS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT