BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.

    FDA Enforcement
    Class II ·Ongoing·BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA·October 21, 2020

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Enforcement
    Class II ·Ongoing·NOA Medical Industries Inc·January 22, 2025

    Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

    FDA Enforcement
    Class II ·Ongoing·YAMAHA MOTOR CORPORATION·May 29, 2024

    Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD

    FDA Enforcement
    Class II ·Ongoing·YAMAHA MOTOR CORPORATION·May 29, 2024

    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    FDA Enforcement
    Class I ·Ongoing·Universal Meditech Inc.·February 8, 2023

    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 6, 2025

    Remington MEDICAL Drainage Bag, REF 600-D;

    FDA Enforcement
    Class II ·Ongoing·Remington Medical, Inc.·December 13, 2023

    Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·January 22, 2025

    Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 8, 2023

    Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·January 22, 2025

    Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·October 29, 2025

    Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·January 22, 2025

    JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·April 26, 2023

    Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

    FDA Enforcement
    Class II ·Ongoing·Ambu Inc.·May 14, 2025

    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.

    FDA Enforcement
    Class II ·Ongoing·SVS LLC·July 17, 2024

    Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

    FDA Enforcement
    Class II ·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025

    PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.

    FDA Enforcement
    Class II ·Ongoing·Nihon Kohden America Inc·February 3, 2021

    Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 26, 2023