Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·OMNISCEPT(TM) KB SYSTEM

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RITHRON-XR CORONARY STENT SYSTEM

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval

SAPIEN 3 Pulmonic Delivery System (S3 PDS)

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·AV PLUS DX, MODEL 1368

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03