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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Safco polycarbonate crowns

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310222393·Safco polycarbonate crowns #30 5/box

    MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANGLED REAMER SLEEVE, 10°

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·June 7, 2024

    ANGLED REAMER, DRIVE SHAFT

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·June 21, 2024

    ANGLED REAMER SLEEVE, 20°

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·June 21, 2024

    ANGLED REAMER, DRIVE SHAFT

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·June 3, 2024

    10MM DRILL

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HWE·February 13, 2024

    LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 26, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·February 28, 2011

    INTRATHECAL CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·March 26, 2008

    BD ALARIS¿ SMARTSITE¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 23, 2023

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014