BEUDAMED
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    Second Opinion

    FDA 510(k)
    FDA Class 2 ·Radiology

    XVWEB

    FDA Adverse Event
    Injury ·PLANET DDS·Product code LLZ·March 13, 2025

    SECOND OPINION

    FDA Adverse Event
    Injury ·PEARL INC.·Product code MYN·March 13, 2025

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517628978·CoRoent Ant TLIF Ti, 11x10x36mm 15°

    BALLARD™

    FDA UDI
    SUNMED, LLC·10889483564301·BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, T-Pi...

    BALLARD™

    FDA UDI
    SUNMED, LLC·10889483564578·BALLARD™ TURBO-CLEANING CLOSED SUCTION SYSTEM F...

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707183486·AccuFit Molar Band UL7 - 36.5

    Ballard* Closed Suction System for Adults

    FDA UDI
    Avanos Medical, Inc.·00609038983127·BALLARD* Closed Suction Catheter, Double Swivel...

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039648·sEEG ANCHOR BOLT DRIVER, FOR 2.4MM DRILL

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707166·Fomon Nasal Rasp 8" (20cm), #5/6, medium, 7 x 4...

    ORTHO CONTROL FEMALE URINARY CONTROL DEVICE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    True 3D Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·May 10, 2023

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 8, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 8, 2013

    BD SYRINGE 60 ML LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·May 8, 2023

    BD SYRINGE 60 ML LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·May 9, 2023

    SYRINGE 50ML LL BRAZIL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·April 5, 2024

    Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE DSE TRACH; e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); f. HALYARD* 14FR TRACH CARE DSE ENDO; g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); h. HALYARD* 14FR TRACH CARE DSE TRACH; i. HALYARD* 14FR DSE 12IN/30.5CM; j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH; k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO; l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO; m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO; n. HALYARD* 14FR TRACH CARE DSE MDI ENDO; o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO; q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE); r. HALYARD* 16FR TRACH CARE DSE ENDO; s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018