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

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    JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143031·

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B582801430300·CURETTE

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033578384·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033578377·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033578391·

    Hydrafacial MD Elite

    FDA UDI
    Hydrafacial LLC·00810007531540·100–120VAC, 50/60Hz, 8A

    ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RANDOX PHENOBARBITAL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ZPower Rechargeable System for Hearing Aids

    FDA UDI
    ZPOWER, LLC·00850034007762·ZPower Rechargeable System for Hearing Aids Kit...

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 6, 2013

    IDENTITY XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·March 13, 2008

    LANTERN DELIVERY MICROCATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·July 25, 2019

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 2014

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022