Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MEMORYGEl BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·S 75-G OTW; S 75-K OTW; S 85-G OTW; S 85-K OTW

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75-BP, COROX OTW 85-BP, COROX OTW-S 75-BP, COROX OTW-S 85-BP, COROX OTW-L 85-BP, COROX OTW-L 75-BP, CELERITY 2

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP; Corox OTW-L BP; Corox ProMRI OTW BP; Sentus ProMRI OTW QP S; Sentus ProMRI OTW QP S-xx/49; Corox OTW-S BP;

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 OTW

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW, COROX OTW-L, CELERITY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW/OTW/CS LEAD

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN OTW & ATTAIN BIPOLAR OTW

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP