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

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    Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319741894·Spratt (Brun) Bone Curette 6-1/2" (16.3cm), siz...

    AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

    FDA 510(k)
    FDA Class 2 ·Hematology

    BEGO SEMADOS S-LINE

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOPOUCH RETRIEVER SPEC BAG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·October 9, 2008

    RIA REAMER HEAD Ø15

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·June 26, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·August 4, 2011

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·July 30, 2019

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020