2,331 results · 21ms · Sources: EU EUDAMED, US FDA

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·Pathway Clinical Trial Cohort

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·Aspire Assist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA®3 dermal filler

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval
FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

KODAK T-MAT C FILM SO-119

FDA 510(k)
FDA Class 3 ·Unknown

KODAK T-MAT H FILM SO-118

FDA 510(k)
FDA Class 3 ·Unknown

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASIST DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES