BEUDAMED
    9 results · 12ms · 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 Status: Open, Classified ×

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DCK·October 11, 2024

    CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

    FDA Recall
    Open, Classified ·Randox Laboratories·Product code DCK·February 1, 2023

    AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.

    FDA Recall
    Open, Classified ·MRP, LLC dba Aquabiliti·Product code NGT·December 28, 2023

    VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DCK·April 14, 2025

    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

    Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

    FDA Recall
    Open, Classified ·TANGENT ENDOSCOPY, LLC·Product code FBN·March 23, 2026

    Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

    FDA Recall
    Open, Classified ·Zhejiang Luyao Electronics Technology Co., Ltd. Pingyang County Wenzhou China·Product code IRP·January 17, 2025

    REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L

    FDA Recall
    Open, Classified ·Compass Health Brands (Corporate Office)·Product code IRP·March 7, 2023

    VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code PPM·May 21, 2024