BEUDAMED
    28 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).

    FDA Enforcement
    Class I ·Ongoing·North American Rescue LLC.·May 6, 2026

    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).

    FDA Recall
    Open, Classified ·North American Rescue LLC.·Product code LRR·March 27, 2026

    Catheter and Glove Suction Kit

    FDA UDI
    C. R. Bard, Inc.·00801741050695·Catheter and Glove Suction Kit

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003728·Medium 6 Hole BSSO Plate

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659276789·K-wire 2.0x190mm,trocar/round, _x000D_...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702627947·ELVAREX 3/KNEE HIGH/CLOSED TOE-ELEPHANTIASIS-VE...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776098230·Spinal Discectomy Retractor

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981161507·Z-Rod, Dia. 6.0mm, Co-Cr, 100mm

    K-wire 2.0x190mm,trocar/round, 2.0x190mm,f.5.0mm FUSION LOCK SYSTEM

    FDA UDI
    mahe medical gmbh·EMAH10201401000·K-wire 2.0x190mm,trocar/round, 2.0x19...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064491·2.0 System 6 Hole Medium BSSO Plate Sterile Qty 2

    DIO STEADY EXTERNAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ARROW ECHOGENIC INTRODUCER NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRILOGY EVO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·February 12, 2024

    PSI 140*100*40 PEEK

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GXN·October 27, 2021

    PSI 140*100*40 PEEK

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GXN·June 23, 2022

    PSI 140*100*40 PEEK

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GXN·July 31, 2023

    PSI 140*100*40 PEEK

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code GXN·July 22, 2022

    PSI 140*100*40 PEEK

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code GXN·March 13, 2023

    PSI 140*100*40 PEEK

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code GXN·March 10, 2023