BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    HLS UNI EVOLUTION PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743649·ACHIMED ACHILLES SUPP SILVER I

    MedGyn Uterine Curette

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803022211·11mm rigid straight curette

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113508·PS-C Insert, Size 2 x 11mm

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776369613·Bimanual Aspirating Unit, Titanium Aspirating H...

    EFILM WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·February 29, 2024

    NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HAW·April 19, 2017

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    POPULAR PLASTICS·Product code IKX·March 26, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 28, 2011

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 26, 2008

    PENUMBRA SYSTEM JET7 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·December 3, 2019

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020