BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Elecsys Anti-HAV II

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017880·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721353·House Alligator Ear Forceps 3" (7.5cm) shaft, s...

    MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    UNKNOWN PRODUCT - CERAMIC ON CERAMIC RIGHT HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code LZO·July 28, 2011

    COBAS 6000 C501MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CGA·June 26, 2013

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024