Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOPAP PRIMARY SCREENING SYSTEM

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·LCS UNI TOTAL KNEE SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST V2

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRO TOPOLYZER VARIO

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRETTO WAVE EYE-Q LASER SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI LINK RX ZETA CORONARY STENT SYSTEM/ MULTI LINK OTW ZETA CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·TruSight Oncology Comprehensive

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Electrical Impedance Spectrometer

FDA Pre-Market Approval

FDA Class 3 ·NEVISENSE

Gastric Emptying Breath Test

FDA classification

FDA Class 3 ·Gastric Emptying Breath Test

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA classification

FDA Class 3 ·Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode