BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Novation

    FDA UDI
    Exactech, Inc.·10885862630339·Hip Elevator

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361009467·PedFuse Reset, CNL, 9.0mm x 65mm

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 15, 2026

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 15, 2026

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 15, 2026

    QUIK-CAP

    FDA 510(k)
    FDA Class 2 ·Neurology

    PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 13, 2013

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·February 16, 2011

    BRILLIANCE 64 SLICE CT SCANNER

    FDA Adverse Event
    Other ·PHILIPS MEDICAL SYSTEMS·Product code JAK·February 12, 2008

    Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Enforcement
    Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    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