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

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    CADWELL 7200

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FAST ABS DELUXE

    FDA Adverse Event
    Injury ·UNK·Product code IPF·January 24, 2002

    TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    SPIRO PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    M2A-MAGNUM PF CUP 56ODX50ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 8, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007

    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code HRX·April 19, 2018

    SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code HRX·June 26, 2019

    Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);

    FDA Recall
    Open, Classified ·MicroAire Surgical Instruments, LLC·Product code EMF·May 7, 2025

    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code GET·March 11, 2016

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025