BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00312281·

    Premier Cavity Prep

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783008296·BLACK CUTTING INSTR 61/62

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159019148·Jacobson Micro Needle Holder Flat Handle

    EXTERNAL FIXATION ANCHOR PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYRINGE 50ML LL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 15, 2021

    VERCISE CARTESIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·October 3, 2024

    BIO-CORKSCREW SUTURE ANCHOR

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 28, 2011

    TRANSTAR PATIENT MOUNT MONITORING KIT

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, ASD.·Product code DRS·February 21, 2008

    Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).

    FDA Recall
    Terminated ·Theken Spine Llc·Product code NOX·August 26, 2010

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    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