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

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    MODEL 4000 EEG MONITOR WITH PSI (PSA4000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PowerPICC Provena Sherlock 3CG

    FDA UDI
    Bard Access Systems, Inc.·00801741228742·Catheter Placement Kit

    X-MARK Ultra

    FDA UDI
    Izi Medical Products, LLC·B8870010690·1.15mm x 3cm X-MARK Ultra Preloaded

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001069·artVeneer life upper anteriors, BXL, A3

    FLEXLINK ULTRAFLEX (ACCU-CHEK)

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·April 23, 2026

    FLEXLINK ULTRAFLEX (ACCU-CHEK)

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·April 23, 2026

    Coveris

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030CS0010690·13mm x 18mm Dual-Convex, 9mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523139910·Reduction Head Adjuster

    RANDOX C-REACTIVE PROTEIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN

    FDA 510(k)
    FDA Class 1 ·Dental

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 22, 2024

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 22, 2024

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 22, 2024

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    SUPER POLIGRIP

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·February 15, 2011

    MPOWER TWO TRIGGER MODULAR HANDPIECE

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC·Product code FCO·February 14, 2008

    STANDARD 8FR FRAZIER WITH VENT

    FDA Adverse Event
    CONMED CORPORATION·Product code JOL·March 22, 2011

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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