2,257 results · 20ms · Sources: EU EUDAMED, US FDA

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA ARTIFICAL SKIN DERMAL REGENERATION TEMPLATE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE

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

CONSENSUS(TM) TOTAL HIP SYSTEM

FDA 510(k)
FDA Class 3 ·Orthopedic

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)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

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

GRAPHIC STRESS TELETHERMOMETRY

FDA 510(k)
FDA Class 3 ·Obstetrics/Gynecology

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

Lenses, Soft Contact, Extended Wear

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