BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO: UNICAP SPECIFIC IGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    Epimed

    FDA UDI
    EPIMED INTERNATIONAL, INC·00818788020048·RX Coudé® Epidural Needle 18g TW x 2.5"

    TEKNO®

    FDA UDI
    Tekno-Medical Optik-Chirurgie GmbH·04044684023623·MAYO-HEGAR NEEDLE HOLDER 18CM TC

    EndoVive Gastrostomy Tube, Straight, with ENFit Connector

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00813939023619·EndoVive Gastrostomy Tube, Straight, with ENFit...

    ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORRECT PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    CELL-DYN DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

    LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·March 11, 2017

    RD SET DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·February 17, 2017

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 10, 2013

    CAPD DISP DISCONNECT, UV FLASH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code KDJ·May 23, 2008

    AIRCAST CRYO/CUFF

    FDA Adverse Event
    Injury ·DJ ORTHOPEDICS DE MEXICO·Product code ILO·April 6, 2011

    RAINBOW RC-4

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

    LNCS TC-I SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·August 31, 2015

    CELL-DYN RUBY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    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