BEUDAMED
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    TAMARIN BLUE PTCA RX DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795137098·Screw Countersink, AO Quick Connect

    TANDA MAX OTC SYSTEM

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

    CLEARFIL DC CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    PASS LP - LIGAPASS

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code JDQ·April 26, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

    SURETEK?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·July 4, 2025

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 14, 2013

    FEMORAL INSERTION HANDLE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·May 19, 2011

    ARTHRO PIERCE 45 DEGREE LEFT

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HRX·August 11, 2008

    PASS LP - LIAPASS

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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