Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN OTW

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN OTW

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV,EVIA HF,EVIA HF-T,ENTOVIS HF,ENTOVIS HF-T,COROX OTW 85 UP STEROID,COROX OTW 75-BP,COROX OTW 85-BP,COROX OTW-S

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead and Attain OTW LV Lead

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead & Attain OTW LV Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead and Attain OTW LV Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead and Attain OTW LV Lead

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V RX/PROMUS RX/XIENCE OTW/PROMUS OTW

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead and Attain OTW LV Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN CS & ATTAIN OTW & ATTAIN BIPOLAR OTW

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead and Attain OTW LV Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead and Attain OTW LV Lead

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW

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

FDA Pre-Market Approval

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

Sentimag System, Sentimark Magnetic Marker Systerm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SLA 532nm 50 um Haag Streit 900 BM w/MM

FDA UDI

IRIDEX CORPORATION·00813125011178·

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)