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

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    MYOSURE ROD LENS SCOPE SEALS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CAIRD TECHNOLOGY HOLTER 2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014

    EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC·Product code MHX·May 1, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 19, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 19, 2011

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 14, 2015

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021