BEUDAMED
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    ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM

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

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750007103·3830A PNT/HTRSHELL/CONN ASSY

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

    SYNTHES 2.4 MM CANNULATED SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEDIACYN ATOPIC DERMATITIS HYDROGEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 3, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    QUADRA R FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026

    smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP; g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS; h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090; i) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090JP;

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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 L131, ESSENTIO DR EL MRI Pacemaker

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