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

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    LENSSX LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    M-Flex®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020296·Blue Silicone Tungsten Hurst Esophageal Dilator...

    SS MATRIX

    FDA 510(k)
    FDA Unclassified ·Unknown

    FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 26, 2022

    M2A 1 PC SHELL 38MMX56MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

    38MM OVAL PATELLA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 14, 2008

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024