BEUDAMED
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    S2 EQUIPMENT LLC

    FDA registration
    S2 EQUIPMENT LLC·1 product·🇺🇸 United States

    RenewTM NCP-5 External Counterpulsation System

    FDA UDI
    S2 Equipment LLC·00865089000316·

    DCI EQUIPMENT TRACK MOUNT LIGHT ASSEMBLY

    FDA Adverse Event
    Malfunction ·DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING)·Product code EAZ·May 30, 2007

    VENTLAB

    FDA Adverse Event
    Malfunction ·VENT LAB LLC·Product code BTM·September 12, 2025

    HEARTSINE SAMARITAN 500P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·January 25, 2016

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·Product code FPA·August 11, 2021

    FLOW-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code BSZ·May 16, 2019

    FREESTYLE HANDS-FREE BREASTPUMP

    FDA Adverse Event
    Injury ·MEDELA AG·Product code HGX·December 27, 2017

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·September 3, 2021

    SONICONE®O.R. SONICVAC

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·December 2, 2024

    ELECSYS TROPONIN T HS STAT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·August 21, 2023

    NEXUS® SONASTAR® LONG HANDPIECE

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·November 5, 2025

    SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·May 9, 2022

    NEXUS® BONESCALPEL®, 20MM, BLUNT BLADE + IRRIGATION TUBING KIT

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·October 8, 2024

    BREASTPUMP PNSA STARTER

    FDA Adverse Event
    Injury ·MEDELA LLC·Product code HGX·June 26, 2018

    AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.

    FDA Recall
    Terminated ·Sky Medical Supplies and Equipments LLC·Product code QKO·January 19, 2021

    Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.

    FDA Recall
    Terminated ·Sound Surgical Technologies, LLC·Product code GEI·December 28, 2007

    ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·December 16, 2014

    Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027

    FDA Recall
    Terminated ·Sound Surgical Technologies, LLC·Product code GEI·December 21, 2010

    Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile; (6) Presource Robotic Module Pack, Cat. SBAOCRBEN8, Englewood Hospital and Medical, Sterile; (7) Presource FMC Liver Resection Pack, Cat. SBA30MJCHH, AHS Calgary Zone, Sterile; (8) Presource ALIF Pack, Cat. SBA41ALFME, USPI Baylor Med Ctr at Fri, Sterile; (9) Presource ACDF Pack, Cat. SBA44ACWBF, Webster Surgical Specialty Hos, Sterile; (10) Presource Lap Chole Pack, Cat. SBA54LADNA, USPI Paso Del Norte Srgry Ctr, Sterile; (11) Presource Lap Chole Pack, Cat. SBA54LADN3, USPI Paso Del Nrte Srgry Ctr, Sterile; (12) Presource Salle Hybride Ensemble, Cat. SCV30THLHA, Inst Univ Cardio ET Pneumo, Sterile; (13) Presource AMB Perc Pack, Cat. SMA57PR00B, Oregon Health Science Universi, Sterile; (14) Presource KP Vacaville Lami Pack, Cat. SNE69LPKVB, KP Vacaville, Sterile; (15) Presource Kyphoplasty Pack, Cat. SOP26KPMHB, Moffitt Cancer Center, Sterile; (16) Presource Percutaneous Nephro Pack, Cat. SOT30PELCA, Lakeridge Health Corporation, Sterile; and (17) Presource PBDS Infection Control Turnover Kit, Cat. ORC511687B, Sequoia Surgery Center LLC, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 18, 2023