BEUDAMED
    19 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

    FDA Recall
    Open, Classified ·Product code OEZ·May 4, 2026

    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

    FDA Recall
    Open, Classified ·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025

    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

    FDA Recall
    Open, Classified ·Product code JIN·October 2, 2023

    NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456

    FDA Recall
    Open, Classified ·NxStage Medical Inc·Product code KPO·May 14, 2024

    Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·August 18, 2025

    ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·August 18, 2025

    Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

    FDA Recall
    Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

    IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·March 24, 2025

    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

    FDA Recall
    Open, Classified ·AtriCure, Inc.·Product code GEH·November 28, 2023

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    FDA Recall
    Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

    Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

    FDA Recall
    Open, Classified ·Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel·Product code GEH·September 16, 2019

    Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

    FDA Recall
    Open, Classified ·AtriCure, Inc.·Product code GEH·November 28, 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 Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·March 24, 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 Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·March 24, 2025

    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code GHH·October 3, 2023

    IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·March 24, 2025