BEUDAMED
    20 results · 35ms · Sources: EU EUDAMED, US FDA

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    SPECIMEN COLLECTORS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788220050·Lumbar Graft Block

    DD cube ONE color

    FDA UDI
    Dental Direkt GmbH·EDDIG8220051·DD cube ONE® color are dental mill blanks made ...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690126492·Adjustable Modular Tibia Tray Trial Size 5

    SYNTHES MIDFACE DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    MAXLOCK EXTREME SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·September 18, 2020

    UNKNOWN SHOULDER HUMERAL CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWS·March 28, 2018

    UNKNOWN SHOULDER GLENOSPHERE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWS·March 28, 2018

    MULTUM

    FDA Adverse Event
    Malfunction ·CERNER CORPORATION·Product code LNX·May 17, 2011

    UNKNOWN SHOULDER HUMERAL BODY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWS·March 28, 2018

    UNKNOWN SHOULDER HUMERAL CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWS·March 28, 2018

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 20, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·October 1, 2012

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·August 23, 2010

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023