BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMP,TSV,4.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 18, 2021

    IMP,TSV,4.1MM,SBM,13

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 18, 2021

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 18, 2021

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 18, 2021

    LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CHI·March 4, 2011

    UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GMX Series Medical Air/Oxygen Blender

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    IMP,TSV,4.1MM,SBM,13

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 31, 2023

    VERSATAP SUTURE ANCHOR

    FDA Adverse Event
    Malfunction ·ORTHO-DESIGN·Product code MBI·September 15, 2025

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 8, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    ACCESS® ACCUTNI¿ REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·September 10, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022