BEUDAMED
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    AQUILEX FLUID CONTROL SYSTEM H112

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

    AQUILEX FLUID CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04250317344779·

    2830 3WAY SLIDE VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00874750009305·2830C 3W MAN SLD 15/10.5MM

    SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    SILJETR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 6/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 15, 2022

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·April 11, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    PFC SIGMARP STB TB IN 3 17.5

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS·Product code NJL·May 19, 2011

    HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDLE AND HAND CONTROL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 11, 2008

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·September 14, 2016

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021