BEUDAMED
    20 results · 30ms · 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.

    BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS

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

    CarePoint Precision

    FDA UDI
    ALLISON MEDICAL, INC.·00786227218052·18G x 1" Poly Hub Needle

    Phonak

    FDA UDI
    Phonak AG·07613275257913·Phonak Audéo V70-13 (beige)

    Phonak

    FDA UDI
    Sonova AG·07613275553107·Phonak Virto B50-10

    4B-SV CORDED REMOTE

    FDA UDI
    PARKS MEDICAL ELECTRONICS, INC.·00816787020083·

    Antibacterial Wound Dressing with Copper #8

    FDA UDI
    MEDCU TECHNOLOGIES LTD·07290018406472·Copper impregnated antibacterial wound dressing...

    FUTURA TOPCAP NON GAMMA-2

    FDA 510(k)
    FDA Class 2 ·Dental

    STEATHSTATION TREATMENT GUIDANCE PLATFORM

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD MAX VAGINAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PQA·June 18, 2021

    BD MAX VAGINAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PQA·June 18, 2021

    COROX OTW-L 85-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NKE·March 26, 2013

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·February 25, 2011

    CURRENT PLUS DR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·August 19, 2014

    AIR OPTIX COLORS

    FDA Adverse Event
    Injury ·CIBA VISION JOHOR SDN, BHD.·Product code LPL·April 29, 2020

    INCLUSIVE TAPERED IMPLANT 4.7MMD X 10MML X 4.5MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 12, 2020

    INCLUSIVE TAPERED IMPLANT 4.2MMD X 8MML X 3.5MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 12, 2020

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    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