2,683 results · 19ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·EXCIMED(TM) UV200LA LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·PREPSTAIN SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC

Salivary Estriol Test

FDA Pre-Market Approval
FDA Class 3 ·SALEST TM SYSTEM

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·Esteem

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SILIKON 1000

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval
FDA Class 3 ·DAKO TOP2A FISH PHARMDX KIT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES-THERAPEUTIC USE

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense®

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ORTHOPAK BONE GROWTH STIMULATOR

Implant, Dermal, For Aesthetic Use

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

Implant, Dermal, For Aesthetic Use

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

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoSense

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·GELFOAM (ABSORABLE GELATIN) POWDER, USP

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

FDA Pre-Market Approval
FDA Class 3 ·ANTI-HBC IGM

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit