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

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    GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809848472·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE LARGE FU...

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124412·Modular Offset Stem 15mm x 100mm x 4mm

    BD NEEDLE ECLIPSE 25X1-1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·October 17, 2024

    IDI-STREP B ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ARTHROCARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012

    COOLCUT

    FDA Adverse Event
    Malfunction ·ARTHREX·Product code HWE·April 4, 2011

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013

    QUANTUM MAVERICK MR BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 22, 2008

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

    Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light.

    FDA Recall
    Terminated ·Stryker Medical·Product code HDD·January 26, 2004

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015