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

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    Ez3D-i/E3

    FDA 510(k)
    FDA Class 2 ·Radiology

    AGXO

    FDA UDI
    Oticon A/S·05707131281241·H160V2, MINIBTE 312 WL 85 CNB AGXO

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 30, 2021

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962161920·WEISMAN GRAVES, RIGHT SIDE OPENING, EXTRA LARGE

    ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOPRO POLAR HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 6, 2013

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Malfunction ·INTEGRA, CINCINNATI·Product code HBL·June 21, 2011

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 3, 2008

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015