Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE/BETA-CATH SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT & SIZING DEVICE

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VITRAX SODIUM HYALURONATE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CM(TM) LENSES

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·X-70 SOFT CONTACT LENS

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)