BEUDAMED
    5 results · 6ms · 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 Classification: Class Ii × Status: Ongoing × Clear all

    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0

    FDA Enforcement
    Class II ·Ongoing·Wishbone Medical, Inc.·February 15, 2023

    IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 7, 2025

    IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 7, 2025

    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

    FDA Enforcement
    Class II ·Ongoing·LTS Therapy Systems, LLC·August 6, 2025

    IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

    FDA Enforcement
    Class II ·Ongoing·LTS Therapy Systems, LLC·August 6, 2025