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

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    Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160311·Integra® Miltex® DeBakey Multi-Purpose Clamp, 6...

    Tecomet

    FDA UDI
    TECOMET INC.·00841435121379·PERIOSTEAL ELEVATOR NARROW CURVED

    IMAGE MEDICAL ACQUISITION STATION (IMAS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    InsufflatOR Needle

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·January 16, 2026

    INT HEX CAP SCR 5.0MM X 45MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDS·November 11, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    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