813 results · 19ms · Sources: EU EUDAMED, US FDA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH PSA WHO STANDARDIZATION

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationFocus CDx BRCA HRD

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM

System, Identification, Contact Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTMARK

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

System, Identification, Contact Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTMARK

Electrode, Stabilized Epidural Spinal

FDA Pre-Market Approval
FDA Class 3 ·SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355

System, Identification, Contact Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTMARK

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EXCIMER LASER SYSTEM EC-5000

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EXCLAIMER LASER SYSTEM EC-5000

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·Nidek EC-5000 Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·EC-5000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM