BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARSENAL PETITE LAPIDUS PLATE, R

    FDA Adverse Event
    Injury ·TRILLIANT SURGICAL·Product code HRS·April 3, 2020

    FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 1, 2008

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 26, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 28, 2011

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013