322 results · 17ms · Sources: EU EUDAMED, US FDA

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

P2psa

FDA Pre-Market Approval
FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

P2psa

FDA Pre-Market Approval
FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

P2psa

FDA Pre-Market Approval
FDA Class 3 ·Access Hybritech p2PSA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEMS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE INJECTABLE GEL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·TORONTO SPV VALVE

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Eterna™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·FLEXTOME CORONARY CUTTING BALLOON

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION PACILITAXEL-ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM