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

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    TRANSFERRIN KIT FOR USE ON THE SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    JOBST soSoft

    FDA UDI
    BSN MEDICAL, INC.·00035664007911·SOSOFT 20-30 MM HG KNEE HIGH RIB EXTRA LARGE SA...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1202360·

    STAIR SYSTEMS PACS & DICOM VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO PASS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·September 26, 2018

    MICRUSFRAME10 6MM X 11.9CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 8, 2022

    TENSION HOLDER F/TEMP-USE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·July 29, 2013

    TENSION HOLDER F/TEMP-USE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·July 29, 2013

    TENSION HOLDER F/TEMP-USE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·July 29, 2013

    SELOX ST 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·May 20, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    NEUROMONITOR BASIC KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC, MEDOS S.A.·Product code GWM·June 7, 2011

    ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JFY·April 19, 2023

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025