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

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    Capere Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154185276·CHEEK RETRACTOR

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180168442·SEALING CAP, FOR 5MM OPERATING SCOPE CHANNEL & ...

    Evans Trial

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224093·TMC Evans Trial, 6mm

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113608·PERIBULBAR NEEDLE 25GA 22MM

    DIGI-PRO TENS, MODEL WL-2204 AND WL-2205

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INCENTIVE SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 18, 2023

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·November 26, 2008

    TRAPEASE FILTER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DTK·June 27, 2013

    SI AVANTI PLUS

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code DRE·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 1, 2013

    GLENOID DRILL SMALL/STD/LARGE

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A.·Product code KWT·June 14, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 9, 2014

    Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2015

    Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 17, 2014

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020