62 results · 51ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM

System, Imaging, Fluorescence

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ AUTOFLUORESCENCE SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·R Series MCU 20.01 software release

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Heart

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·OCS Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System