10,000 results · 44ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA MRI IPG,RELIA IPG

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·STRAUMANN EMDOGAIN

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS, ISOFLEX S/P, AND ISOFLEX OPTIM LEADS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD Totalys SlidePrep

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV 16/18

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HC2 HIGH RISK HPV DNA TEST AND DIGENE HC2 HPV DNA TEST

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·TRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·2490G/H/J CARELINK MONITOR, 2020A CARDIOSIGHT READER

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus Microstent

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBc IgM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix MRI Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval
FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIOLINK VASCULAR CLOSURE SYSTEM