BEUDAMED
    18 results · 21ms · 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 Regulation: Us FDA ×

    MODIFICATION TO MALE TO MALE LUER ADAPTER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085022154·816085022260

    QUASAR

    FDA UDI
    Modus Medical Devices Inc·G34350037120·MRgRT Insight - MV Target

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003505·Dennis Micro Forceps, RH, curved DD platform ti...

    LINK Endo-Model EVO Knee System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575185320·Replacement set, CoCrMo, UHMWPE, rotating hinge...

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    3D ACTIVETRAC

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PORTABLE INTENSIVE CARE UNIT, MODEL PIC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OPTISOL-GS CORNEA STORAGE MEDIA

    FDA Adverse Event
    Injury ·ALLIANCE MEDICAL PRODUCTS·Product code LYX·August 15, 2012

    CARDIOSAVE HYBRID W/ E/F PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·September 3, 2025

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·February 11, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 23, 2011

    SETROX S 60

    FDA Adverse Event
    Malfunction ·BIOTRONIK GMBH & CO.·Product code DTB·February 15, 2008

    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

    FDA Enforcement
    Class II ·Ongoing·Luminex Molecular Diagnostics Inc·October 16, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024