BEUDAMED
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    OPERATIVE EAR CURRETTES & RELATED ITEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Integra® Total Foot System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780119012·The locking forefoot screw is used in the Integ...

    Total Foot System 2

    FDA UDI
    Smith & Nephew, Inc.·00885556838624·2.2MM PLATE LOCKING SCREW 6MM

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127888·Adjustable Modular Tibia Tray Trial Size 6

    VQ ORTHOCARE

    FDA UDI
    Vision Quest Industries Incorporated·00817717020456·OACTIVE2 OTS Standard LEFT

    VQ ORTHOCARE

    FDA UDI
    Vision Quest Industries Incorporated·00817717020463·OACTIVE2 OTS Heavy Duty LEFT

    Partial Pelvis Replacement

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575048632·Hook for obturator foramen

    G-SCAN BRIO

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONDUCTIVE GEL

    FDA 510(k)
    FDA Class 2 ·Neurology

    UV FLASH TRANSFER SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 20, 2014

    840 VENTILATOR

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

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·August 25, 2010

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·August 26, 2019

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT 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.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021

    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