BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    URS-IG (GLUCOSE TEST)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101328·Burs FG Metal Cutting 558, Pkg/10

    SAV

    FDA UDI
    Diversified Products, Inc.·00037741702030·

    Flex

    FDA UDI
    Diversified Products, Inc.·00037741502036·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157695·

    3M™ Unitek™ Uni-Twin™

    FDA UDI
    3M UNITEK CORPORATION·00652221015662·Mini Uni-Twin(TM) Bracket Andrews U/L 5x5 3,4,5...

    NA

    FDA UDI
    STRYKER CORPORATION·07613154623884·Cannulated Tibial Plug

    NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HARDYDISK TICARILLIN 75MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    OWL

    FDA UDI
    Diros Technology Inc·00825114002395·OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED ...

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·March 25, 2013

    NI

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KTT·March 7, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2008

    BLOOD PUMP PU VALVES 15 ML, IN/OUT 9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·July 6, 2020

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·March 25, 2021

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012