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

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    Soniquence RF Generator and Soniquence Electrodes

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

    ZenFlex CM

    FDA UDI
    Kerr Corporation·00195062145674·.20/.06/25mm ZenFlex CM NiTi FILE REFILL PACK

    UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RAPID PROGRAMMER

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARENCHYMAL PRESSIO CATHETER 2

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·September 17, 2018

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 8, 2011

    2520274-2013-02315

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·June 22, 2013

    Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc.·October 22, 2025

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025