878 results · 27ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ISERT MODEL 251 PRELOADED POSTERIOR CHAMBER IOL LEVEL B MODIFICATION OF PARENT IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CLARISERT PRELOADED IOL SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AF-1 Family of Intraocular Lens (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Preloaded System/ iSert Micro Injector

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ISERT GEMETRIC

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Intraocular Lenses (IOLs)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Preset Tips

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IPure Preloaded IOL System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBSAG TEST SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS Therapy System

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion Systems

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED(TM) INFUSION SYSTEM