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

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    MICTEC ENDOSCOPES AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·May 5, 2023

    THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES

    FDA 510(k)
    FDA Class 2 ·Hematology

    GLUCANPRO CREAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 13, 2013

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Other ·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·February 8, 2008

    PINN CAN BONE SCREW 6.5MMX20MM

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM·Product code NDJ·September 21, 2012

    PINNACLE SECTOR II CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code LPH·September 21, 2012

    PINN MAR +4 10D 36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code LPH·September 21, 2012

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code JDI·September 21, 2012

    PINN CAN BONE SCREW 6.5MMX30MM

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM·Product code NDJ·September 21, 2012

    SUMMIT DUOFIX TAP SZ7 HI OFF

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code LPH·September 21, 2012

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025

    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

    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