BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253

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

    PROCARE

    FDA UDI
    DJO, LLC·00888912393355·QUICK-RELEASE ZIPPER BDYHLDR, XL,8/pk

    800 P37,IN,1L,2LD,NO TALKBACK,STKR

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828100908·800 P37,IN,1L,2LD,NO TALKBACK,STKR

    MYVACET 5-07, 7-00 AND 9-40

    FDA 510(k)
    FDA Class 2 ·Radiology

    MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN

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

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·March 6, 2013

    POLYFLUX REVACLEAR DIALYZER

    FDA Adverse Event
    Death ·GAMBRO RENAL PRODUCTS·Product code KDI·February 10, 2011

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024