Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·PMA NIT-OCCLUD PDA

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS CORNEAL IMPLANTS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS CORNEAL IMPLANTS

Cardiac Ablation Percutaneous Catheter

FDA classification

FDA Class 3 ·Cardiac Ablation Percutaneous Catheter

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290

FPC/SFPC/RFPC ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

CPS ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·T-SCAN 2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TS2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TRANSCAN T-SCAN 2000

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Aspiration Therapy System

FDA Pre-Market Approval

FDA Class 3 ·AspireAssist