588 results · 28ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed Swivel

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRO Topolyzer VARIO and Patient Bed Swivel

Gonococcal Antibody Tests

FDA Pre-Market Approval
FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Reply/Esprit (5th generation) Electric Hybrid Module

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Zoll R Series

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AutoDELFIA hAFP Test System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP TEST SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AutoDELFIA hAFP Test System

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP TEST KIT

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval
FDA Class 3 ·PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER