Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS DR+ -B PULSE GENERATOR

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·Falope Ring Bands

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT II STENT GRAFT SYSTEM

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

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP SYSTEM (BHR)

PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB

FDA 510(k)

FDA Class 3 ·Cardiovascular

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE

Programmer, Pacemaker

FDA Pre-Market Approval

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

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

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

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·ADX PULSE GENERATOR