BEUDAMED
    61 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)

    FDA Enforcement
    Class II ·Ongoing·Church & Dwight Inc·April 19, 2023

    Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·February 4, 2026

    Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100

    FDA Enforcement
    Class II ·Ongoing·Wondfo USA Co Ltd·June 19, 2024

    SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Surgical, Inc.·May 24, 2017

    Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.

    FDA Enforcement
    Class II ·Ongoing·SEDECAL SA·May 8, 2024

    Medline EBSI Kit EBSI1534

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Easy Diagnost Eleva Universal Fluoroscopic applications

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·December 11, 2013

    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·July 3, 2013

    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·November 9, 2022

    Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 27, 2012

    Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

    FDA Enforcement
    Class II ·Terminated·Kinsman Enterprises Inc·October 27, 2021

    Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·December 11, 2013

    DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

    FDA Enforcement
    Class II ·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025

    Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·February 16, 2022

    Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·February 13, 2013

    RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·June 18, 2014

    Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·July 25, 2012

    Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·August 22, 2012

    Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·May 2, 2018