BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ELAN 4 Electro Motor System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113936·GIANNETTI "BIG SPURT" CANNULA 21GA

    GLUCOSE-SL-C ASSAY, MODEL 257-30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALOKA SSD-4000

    FDA 510(k)
    FDA Class 2 ·Radiology

    CERAMIC MODULAR HEAD

    FDA Adverse Event
    Injury ·BIOMET, INC.·Product code LZO·June 12, 2006

    URETEX TO KIT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·March 27, 2013

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NKM·October 27, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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