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

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    STERRAD® NX Sterilizer with ALLClear™ Technology

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Portex

    FDA UDI
    ICU MEDICAL, INC.·00351688012084·

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024732·B-P MODULAR EXTENSION W/ULTRACOAT - 18 MM X 200 MM

    ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    CAPTURED HIP SCREW LAG SCREW

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    UNKNOWN SPINAL CORD STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·July 7, 2011

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·August 27, 2020

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, SCS·October 15, 2025