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

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    AIR-FLOW HANDY 3.0 PERIO

    FDA 510(k)
    FDA Class 1 ·Dental

    RC Screw-retained Abutment

    FDA UDI
    BIO CONCEPT Co., Ltd.·06947600303473·

    AGXO

    FDA UDI
    Oticon A/S·05707131257796·H150, BTE 13 WL 100 SGR AGXO

    XCELA

    FDA Adverse Event
    Injury ·PFM MEDICAL CPP SA·Product code LJT·October 24, 2024

    INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AUTOSET SPIRIT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    MICRO-TECH

    FDA Adverse Event
    Injury ·STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIV.·Product code KMI·June 16, 2011

    ITREL 3

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·May 29, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020