BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC.·Product code LFL·December 12, 2005

    JOSTRA ARTERIAL PERFUSION CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HRH-63 HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    COULTER LH 750 HEMATOLOGY ANALYZER

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

    8CM HEAVY DUTY MEDIUM ATTACH

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013

    CONTAK RENEWAL 2

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    OPTIBOND SOLO PLUS

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code KLE·April 6, 2011

    PEEK CAGE, UNKNOWN TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·February 9, 2021

    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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