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

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    CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GC Fuji ORTHO™

    FDA UDI
    Gc America Inc.·14548161332002·Fuji Ortho Band LC Paste Pak SL

    GC Fuji ORTHO™

    FDA UDI
    Gc America Inc.·D0470135731·Fuji Ortho Band LC Paste Pak SL

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 17, 2021

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508220·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508237·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508213·

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 16, 2021

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 18, 2021

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 18, 2021

    HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM

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

    DIFFUSION TENSOR IMAGING OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS INC.·Product code QFG·November 26, 2025

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·October 10, 2013

    ADVANTAGE SERIES 29 OBS10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 20, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 10, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015