272 results · 18ms · Sources: EU EUDAMED, US FDA

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOCLAIRE

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·KONING BREAST CT (MODEL CBCT1000)

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL® Absorbable Hemostats (SURGICEL® POWDER™)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ML8 CORONARY STENT SYSTEMS

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval
FDA Class 3 ·MLI 1000 ND:YAG OP LASER

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION AND ML8 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION AND ML8 CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION & ML8 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX ML-8

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX; ML-8

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMDOGAIN

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·SECURE -C CERVICAL ARTIFICIAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C Cervical Disc Prosthesis Two-level

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRESTIGE LP Cervical Disc

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·IN MOTION LUMBAR ARTIFICIAL DISC