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

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    SPECIALTY ASSAYED CONTROL-2

    FDA 510(k)
    FDA Class 2 ·Hematology

    PIVOT Medium Bubblegum Prophy Pack Box 100

    FDA UDI
    Preventech·D0241100103·PIVOT Medium Bubblegum Prophy Pack Box of 100 u...

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517174321·MaXcess Micro Decomp Kerrison, 2mm 90°

    SmileSet Impression Kit - Retainer

    FDA UDI
    Ortho Dental Lab LLC·00850078989369·

    DURAVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948004649·DURAVENT 1 IC, SIZE 3

    RHEAD

    FDA UDI
    Stryker GmbH·00886385023335·Standard Extended Stem, 6mm Collar, Size 4

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869634373·MOSS VRS Shank Inserter, star 20, 1/4" coupling

    SURSHIELD WINGED INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AVL OPTI R ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 3, 2021

    FINESSE

    FDA Adverse Event
    Malfunction ·AMEDA, INC.·Product code HGX·October 16, 2020

    AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS

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

    LEGACY3 IMPLANT

    FDA Adverse Event
    Malfunction ·IMPLANT DIRECT LLC·Product code DZE·October 9, 2017

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICE GROUP·Product code FRN·April 29, 2013

    I-STAT ACTC (CELITE)

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.·Product code JBP·May 16, 2011

    XCEL DILATING TIP TROCAR 11MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 5, 2008

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 13, 2023

    rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011