BEUDAMED
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    FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US

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

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10888277781900·POST PARTUM ENHANCED KIT

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094069877·Welch Allyn Ambulatory Blood Pressure Cuff Kit;...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540134028·MANDIBULAR BODY RETRACTOR

    HARDYDISK CEFONICID, 30 MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO EXCITE

    FDA 510(k)
    FDA Class 2 ·Dental

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013

    DUROM US ACETABULAR COMPONENT 46/40 F

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 17, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·August 6, 2008

    CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 14, 2017

    CANTATA 2.8 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·November 17, 2017

    CANTATA 2.5 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·September 17, 2018

    CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·September 11, 2018

    CANTATA 2.5 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·July 28, 2017

    CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·June 15, 2017

    CANTATA 2.5 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·May 30, 2018

    CANTATA 2.8 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·September 6, 2018

    Lipo Pack, part AMS4420(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019