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

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    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JIX·October 26, 2023

    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JIX·October 26, 2023

    Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·November 13, 2023

    Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·July 19, 2023

    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JIX·October 26, 2023

    Calibration Serum Level 3 CAL2351

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·November 20, 2023

    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·March 1, 2024

    ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JIX·April 24, 2025

    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JIX·October 26, 2023

    Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·November 20, 2023

    Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·March 5, 2024

    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

    FDA Recall
    Open, Classified ·AMS Diagnostics, LLC·Product code JIX·February 29, 2016

    MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS) Catalog # NC0585129

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JSM·May 25, 2022

    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

    FDA Recall
    Open, Classified ·SEASPINE ORTHOPEDICS CORPORATION·Product code HWJ·June 4, 2024

    S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD

    FDA Recall
    Open, Classified ·Stryker Communications·Product code FQO·January 29, 2021

    Azurion IGTS Fixed Systems

    FDA Recall
    Open, Classified ·Philips North America·Product code OWB·October 4, 2023

    Allura Xper IGTS Fixed Systems

    FDA Recall
    Open, Classified ·Philips North America·Product code OWB·October 4, 2023

    Integris-Allura IGTS Fixed Systems

    FDA Recall
    Open, Classified ·Philips North America·Product code OWB·October 4, 2023

    PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.

    FDA Recall
    Open, Classified ·B BRAUN MEDICAL INC·Product code OGE·September 18, 2025

    AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

    FDA Recall
    Open, Classified ·Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany·Product code HBB·August 18, 2025