BEUDAMED
    19 results · 29ms · 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 ×

    HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481288·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481271·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481301·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033481295·

    MAMMARY PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN HEYER-SCHULTE·Product code FTR·April 17, 1998

    DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

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

    ACROTHERM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 9, 2013

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 9, 2017

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·March 20, 2013

    TRABECULAR METAL MODULAR ACETABULAR SHELL

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·March 8, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 10, 2008

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 15, 2025

    CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 23, 2023

    UNK LINX MAGNETIC IMPLANT

    FDA Adverse Event
    Injury ·TORAX MEDICAL, INC.·Product code LEI·September 23, 2019

    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