BEUDAMED
    14 results · 31ms · Sources: EU EUDAMED, US FDA

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    INTERLAB IMMUNOFIXATION TEST(S)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033187·Baltic Denture System BDLoad BDLoad ↓ Lm6 PLSEu...

    KSEA SPINOSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VACUCATH I.V. CATHETER INTRODUCTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 7, 2025

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·March 31, 2018

    28MM DIA COCR MOD HD -3MM NK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·November 28, 2018

    TPRLC 133 TYPE1 PPS HO 10.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 11, 2018

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 1, 2013

    STRYKER GO BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·February 28, 2011

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·April 23, 2008

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016