7 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·August 26, 2015
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
Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
FDA Enforcement
Class II
·Terminated·Burlington Medical, LLC·August 7, 2019
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