1,107 results · 21ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ENDOTOXIN TEST METHOD

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Tryton Side Branch Stent

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFT-FORM 55EW; LL-55; SOFTCON EW2

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·STAT PACE II

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Cordis® PALMAZ® Balloon-Expandable Stent

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON® (senofilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·EXOSEAL VASCULAR CLOSURE DEVICE

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/ON RAPTORRAIL STENT DELIVERY SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·NOVATION CERAMIC ARTICULATION HIP SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses