Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and

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

FDA Pre-Market Approval

FDA Class 3 ·ISOFLEX FAMILY OF LEADS (1944,1948)

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

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL AND OPTISENSE FAMILY OF LEADS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER TRANSPORTABLE (DLT)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·REVOLUTIONS (TM) ALT. MANU. SITE CONTACTS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLINUS-ELTING PLATINUM CHROMINUM CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT

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)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·UNISOL

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