BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    REMREST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DURA-CUF

    FDA UDI
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682110457·DURA-CUF, SMALL ADULT LONG, 1 TB SCREW, 17 - 25...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450237465·

    PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CRIT-LINE MONITOR III (CLM III)

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

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 1, 2025

    ASSURITY MRI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·October 15, 2025

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 15, 2026

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 13, 2013

    ASR 300 SPIKED CUP SIZE 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 26, 2008

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

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

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