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

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    EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017862·Wide Jaw Punch large 3.5mm 45 degree left

    Trulink

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101892·ADAPTER,EEG LEADWIRES,4 LEAD

    Trulink

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101885·ADAPTER,EEG LEADWIRES,2 LEAD

    QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIDENT ELEVATED RIM LINER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUSION¿ ENT NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 2, 2019

    SCORPIO TS MOD. TIB. TRAY

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 20, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 26, 2014

    CAPSURE SP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 10, 2011

    EAGLE EYE PLATINUM SHORT TIP

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    CASH 14 PLAT COIL 4MMX6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    GALAXY G3 MINI 3MM X 6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    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