BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    MOLECULAR ADSORBENT RECIRCULATING(MARS)

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

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750000036·7500 EX SM 22OD ELB W/STD HDGR

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493858·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795021239·

    TINA-QUANT HBA1C GEN.2

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEPARIN ASSAY CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    PRODIGY SM STAT SHT LT 10.5MM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 15, 2013

    SOL SYS 10.5 STD 6IN

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 20, 2011

    TRIDENT PSL HA CLUSTER 54MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 12, 2008

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    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