BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bard® LeFort Metal Sound

    FDA UDI
    C. R. Bard, Inc.·00801741032509·Bard LeFort Metal Sound, Threaded Tip, Stainles...

    Entuit Thrive LP

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00827002356931·

    REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·November 2, 2010

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 5, 2009

    VERTEX RECONSTRUCTION SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·July 23, 2010

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·April 2, 2010

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·November 20, 2009

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 31, 2016

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 4, 2013

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP FOR EXPORT REFURB

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE SIGNAPORE·Product code FRN·April 6, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 12, 2025

    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code ETD·October 17, 2012

    Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures.

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code KNY·April 15, 2011

    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