BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    SOUNDBITE HEARING SYSTEM BY SONITUS

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

    Heart® Continuous Nebulizer, Pediatric Kit

    FDA UDI
    WESTMED, INC.·00709078000089·Heart® Continuous Nebulizer, Pediatric Kit

    Oticon

    FDA UDI
    Oticon A/S·05707131163110·ACTO PRO, MINIRITE SGR

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494461989·Bone Chisel Blunt Silicone Handle D 3.0mm, WL ...

    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

    FDA 510(k)
    FDA Class 2 ·Hematology

    EXHALE DOPPLER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 24, 2019

    014 HT WINN GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·May 8, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·May 17, 2011

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 5MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 3MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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