Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis

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

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT™ Admiral™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Aspire Cristalle Digital Breast Tomosynthesis Option

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Remodulin

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·ASPIRE Cristalle Breast Tomosynthesis System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST II PMA FAMILY OF IMPLANTABLE PULSE GENERATORS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·8085 PREVAIL IMPLANTABLE PULSE GENERATOR

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·AGENT Paclitaxel-Coated Balloon Catheter

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE)

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

DEPUY ASR TAPER SLEEVE ADAPTER

FDA 510(k)

FDA Class 3 ·Orthopedic

DEPUY ASR 300 ACETABULAR CUP SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic