139 results · 21ms · Sources: EU EUDAMED, US FDA

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON EDGE AND TECNIS FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACANALYSIS CDX

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACANALYSIS CDX DEVICE

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACANALYSIS CDX

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx Device

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACANALYSIS CDX

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx®

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·myChoice CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACANALYSIS CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·MyChoice® CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx®