BEUDAMED
    84 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Urinary Control System with and without Inhibizone

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus® UBT System

    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

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus UBT System

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus UBT System

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus Urea Breath Test System

    PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter (AUS)

    Programmer, Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE

    Programmer, Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE

    Programmer, Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D

    Ring, Endocapsular

    FDA Pre-Market Approval
    FDA Class 3 ·MORCHER® EYEJET® CTR Single-Use Injector

    Programmer, Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03