BEUDAMED
    46 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Ongoing × Clear all

    BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200

    FDA Enforcement
    Class III ·Ongoing·Becton Dickinson & Company·March 2, 2022

    Akreos, SKU: AO60P0300. Akreos intraocular lenses

    FDA Enforcement
    Class III ·Ongoing·Bausch & Lomb Surgical, Inc.·September 3, 2025

    FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

    FDA Enforcement
    Class III ·Ongoing·Owens & Minor Distribution, Inc.·February 15, 2023

    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095

    FDA Enforcement
    Class III ·Ongoing·R & D Systems, Inc.·July 27, 2022

    abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089

    FDA Enforcement
    Class III ·Ongoing·S & MOHR AMERICA, S.A. DE C.V.·March 1, 2023

    Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.

    FDA Enforcement
    Class III ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·April 3, 2019

    Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.

    FDA Enforcement
    Class III ·Ongoing·Baxter Healthcare Corporation·October 5, 2022

    The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.

    FDA Enforcement
    Class III ·Ongoing·Qualigen Inc·January 15, 2025

    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

    FDA Enforcement
    Class III ·Ongoing·Olympus Corporation of the Americas·May 31, 2023

    Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.

    FDA Enforcement
    Class III ·Ongoing·AMEDA, INC.·February 21, 2018

    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

    FDA Enforcement
    Class III ·Ongoing·Olympus Corporation of the Americas·May 31, 2023

    NavaClick Syringe and Needle, Model Number LIN02

    FDA Enforcement
    Class III ·Ongoing·LINEAGE BIOMEDICAL, INC·August 14, 2024

    CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012

    FDA Enforcement
    Class III ·Ongoing·Maquet Medical Systems USA·December 27, 2023

    Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

    FDA Enforcement
    Class III ·Ongoing·Fresenius Medical Care Holdings, Inc.·January 3, 2024

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    FDA Enforcement
    Class III ·Ongoing·NeuMoDx Molecular Inc·July 12, 2023

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Enforcement
    Class III ·Ongoing·Alcon Research LLC·November 27, 2024

    One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

    FDA Enforcement
    Class III ·Ongoing·Home Health US, Incorporated·October 29, 2025

    NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

    FDA Enforcement
    Class III ·Ongoing·NuVasive Inc·February 15, 2023

    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

    FDA Enforcement
    Class III ·Ongoing·Preat Corp·March 15, 2023

    ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options

    FDA Enforcement
    Class III ·Ongoing·Immersivetouch Inc·May 27, 2020