BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618

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

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331138904·brackman suction tube, offset suction tip holes...

    WEITLANER RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048515·WEITLANER RETRACTOR SHARP TIPS

    HS Twist Burr, Ø1.5x12, 80k

    FDA UDI
    Bien-Air Surgery SA·17630055507577·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450174913·

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361005599·Arena-L, Lordotic 10 degrees, 38X28X16

    DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYRINGE 30ML LL BNS

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·August 20, 2021

    SYRINGE 30ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·July 18, 2024

    SYRINGE 30ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·July 18, 2024

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·May 8, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·May 17, 2011

    TREVO XP PROVUE 4MM X 30MM

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 8MM X 31G 1ML/CC

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 13, 2023

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 8MM X 31G 1ML/CC

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 13, 2023

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025