BEUDAMED
    23 results · 23ms · Sources: EU EUDAMED, US FDA

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    BAHADIR STERILIZATION TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REPICCI II RESURFACING KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304006898·

    COVERIS

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030CS1021460·Trial, 15mm x 18mm Lordotic 7°, 12mm

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021460·SPIRA®-A Integrated,Trial, 32x38mm, 8° Lordotic...

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 28, 2023

    KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVOLVE EPS ORTHOLOC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·December 9, 2019

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON-IRVINE TECHNOLOGY CENTER·Product code HQC·May 3, 2013

    CODMAN LUMBAR CATHETER KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·September 19, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

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

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021