BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArgenZ ST 98x14 ML A4B

    FDA UDI
    ARGEN CORPORATION, THE·D818130129·Dental porcelain/ceramic restoration kit

    SLOTTED SPONGE FORCEPS, 15CM

    FDA UDI
    W.H. Holden, Inc.·D9281301290·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450190081·

    devemed

    FDA UDI
    devemed GmbH·04061644037803·GENTLE EXTRACT SYSTEM KIDS | F-LINE Extracting ...

    AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS INTEGRA 400

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 30, 2008

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·November 5, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 19, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 24, 2013

    AGILIS? NXT STEERABLE INTRODUCER DUAL-REACH? 71 CM SHEATH, MEDIUM CURL, 8.5 F

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DYB·September 30, 2014

    MAXIMO DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011

    VITROS 250 CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·September 16, 2014

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 25, 2013

    Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·May 20, 2026

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 24, 2016

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020