BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable Sensor

    FDA UDI
    Honeywell Healthcare Solutions GmbH·04036616009331·Disposable Sensor DA-2211-1L Nellcor

    Rochester

    FDA UDI
    ROCHESTER ELECTRO-MEDICAL, INC.·10816843020252·DISPOSABLE EEG CUP ELECTRODES: 9 MM STAMPED TIN...

    Rochester

    FDA UDI
    Advantage Medical Electronics, LLC·00849593015769·DISPOSABLE EEG CUP ELECTRODES: 9 MM STAMPED TIN...

    MODEL APS ALTERNANS PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO

    FDA 510(k)
    FDA Class 1 ·Dental

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·July 12, 2024

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 12, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Other ·BIOTRONIK SE & CO., KG·Product code NVZ·February 17, 2011

    ALENTI

    FDA Adverse Event
    Injury ·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·February 25, 2008

    HERO GRAFT

    FDA Adverse Event
    Death ·HEMOSPHERE, INC.·Product code DSY·March 20, 2013

    PICC-NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024