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

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    FALCON DISK DRIVE SUBSYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DELTRAN

    FDA UDI
    UTAH MEDICAL PRODUCTS, INC.·H6719026430·Disposable Pressure Transducer, 48" Cable

    SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLUID SOAKERSHIELD

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AMS SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTN·June 30, 2014

    ASKU

    FDA Adverse Event
    Death ·MEDTRONIC MILACA INC.·Product code DTE·November 18, 2010

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 8, 2013

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Death ·ABBOTT MEDICAL·Product code NKM·June 28, 2024

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NKM·June 28, 2024

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017

    THERAPY COOL PATH ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, INC.·Product code LPB·October 31, 2008

    RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.

    FDA Enforcement
    Class I ·Terminated·BASE 10 GENETICS INC·February 23, 2022

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    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