BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    10M - Southwest Gas Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp

    Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772344116·PROTECT.PRO ACTION BACK SUPPORT BLACK M

    24M - Southwest Gas Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588010441·24M - Southwest Gas Corp

    Atos Medical

    FDA UDI
    ATOS MEDICAL INC.·00817126020153·Laryngectomy Pulmonary Kit 10/36 With Provox® F...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523141449·SL Universal Acetabular Trial Shell, 43mm

    KAWASUMI LABORATORY BLOOD DRAWING KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC

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

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 6, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 6, 2013

    LARGE MOD HEAD ADAPT 12/14 +5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·October 27, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

    RATCHETING SCREWDRIVER HANDLE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·March 9, 2022

    UNKNOWN HIP ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 10, 2019

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 10, 2019

    UNKNOWN HIP FEMORAL AUGMENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 10, 2019

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020