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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune System

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune Gio

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune Gio

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune Gio

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune Gio

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune® Gio

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH-GTO

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM Septal Occluder (GSO)

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE® CARDIOFORM Septal Occluder (GSO)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) (GTO)(TM) DEVICE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM),SCA-EX(TM), SCA-EX 7 FRENCH GRAFT AND ATHEROCATH-GTO(R)

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS SPACER SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·SUPERION INTERSPINOUS SPACER

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·SUPERION INDIRECT DECOMPRESSION SYSTEM