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

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    ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450460467·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132160·Trial, TLIF, 27L OB CRV 7Deg, 16mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033471005·

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·January 19, 2026

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·January 20, 2026

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·January 19, 2026

    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEMP 3

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SEE H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 20, 2013

    NEXGEN STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code JWH·March 8, 2011

    METASUL ACETABULAR INSERT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWB·March 14, 2008

    PKG, BIPOLAR FORCEPS, PADDLE, 45CM, P/N 0250080351. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014