BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    ECG RECALL & EDIT PRODUCT VERSION-A3601

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707062240·TUBE MIM 22 L

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668118214·McPherson NdlHldr, X-Del, Cvd, W/Lock

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450053126·

    ADAPTOR,1,P1802,S1802,(2)1/4",TV,N

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828119122·ADAPTOR,1,P1802,S1802,(2)1/4",TV,N

    LTM WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SIMPLICITY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD PHASEAL¿ INJECTOR LUER LOCK N35C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 3, 2018

    PORTEX BIVONA CUFFLESS TRACHEAL TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code BTR·May 9, 2019

    DEPUY ASR XL FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 23, 2012

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 9, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 16, 2010

    SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 18, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    PROPONENT DR SL (Model L201)

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

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024