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

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    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113622·PERIBULBAR NEEDLE 25GA 32MM

    Pisces Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NGSgo® Pronto demo Wash reagents

    FDA UDI
    GenBio·00613745003719·

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114155·KRATZ POLISHER 23GA END (PK/10)

    COBE HC 700 MIDI HEMOCONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    840 VENTILATOR

    FDA Adverse Event
    Death ·PURITAN-BENNETT CORP.·Product code CBK·October 17, 2008

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 2, 2013

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    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 MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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