BEUDAMED
    20 results · 27ms · Sources: EU EUDAMED, US FDA

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    HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607672·STERIS-AMSCO 1080, 2080 3.25" SOFTCARE PLUS

    BONASTENT® Biliary

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369461207·

    POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INFANT LIMB HOLDER, MODELS 306080 & 306081

    FDA 510(k)
    FDA Class 1 ·General Hospital

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 17, 2024

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·October 29, 2009

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·August 3, 2009

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·May 19, 2009

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·April 26, 2013

    DATASCOPE

    FDA Adverse Event
    Malfunction ·MINDRAY·Product code MHX·September 4, 2014

    AU681-02E CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 9, 2026

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JPA·May 21, 2009

    INRATIO

    FDA Adverse Event
    Injury ·BIOSITE, INC.·Product code JPA·March 18, 2009

    BUBBLE CPAP SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 15, 2016

    Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·March 25, 2020

    Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16

    FDA Enforcement
    Class II ·Terminated·TriMed Inc.·June 27, 2018

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024