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

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    ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383514804·"An absorbent paper points is an endodontic pap...

    BLACKHAWK Cervical Spacer System

    FDA UDI
    Choice Spine, LP·00840996164511·BLACKHAWK,STERILE,LORDOTIC,16X14X9

    LIVESURE AMPHETAMINE SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BOSTON BAND

    FDA 510(k)
    FDA Class 2 ·Neurology

    EASYPOINT NEEDLE

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

    EASYPOINT NEEDLE

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

    1823260-2017-01518

    FDA Adverse Event
    Malfunction ·July 24, 2017

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023