BEUDAMED
    6 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement × Status: Ongoing × Clear all

    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18

    FDA Enforcement
    Class II ·Ongoing·Diversatek Healthcare·April 29, 2026

    Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08

    FDA Enforcement
    Class II ·Ongoing·Diversatek Healthcare·April 29, 2026

    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15

    FDA Enforcement
    Class II ·Ongoing·Diversatek Healthcare·April 29, 2026

    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

    FDA Enforcement
    Class II ·Ongoing·Diversatek Healthcare·April 29, 2026

    Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

    FDA Enforcement
    Class III ·Ongoing·Diversatek Healthcare·August 20, 2025

    ZVU Functional GI Software, REF: ZVU-3

    FDA Enforcement
    Class III ·Ongoing·Diversatek Healthcare·September 13, 2023