BEUDAMED
    87 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    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 ·PreVue Pre-loaded System, IPURE Pre-loaded System

    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 ·PreVue Pre-Loaded System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT (ORIGINAL AND PRE-MIXED)

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·AAV5 DetectCDx®

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·AAV5 DetectCDx

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·GASTRIC EMPTYING BREATH TEST (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

    Salivary Estriol Test

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

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13 C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System