BEUDAMED
    33 results · 20ms · Sources: EU EUDAMED, US FDA

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    FLIGHT 60 VENTILATOR, MODEL F-60

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oticon

    FDA UDI
    Oticon A/S·05707131165442·ACTO, ITC/ITE AP WL R BE

    DEBAKEY DERRA CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921007530·DEBAKEY DERRA CLAMP REVERSE ANGLED

    NITANIUM® ARCHWIRE SPRINGS

    FDA UDI
    Ortho Organizers, Inc.·00190707060503·.014 x .030 Nitanium® Open Coil Spring -15" Spo...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450158777·

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494463990·Mighty Chisel right-bended D 5 mm, length 120mm

    MATTIOLI PULSE TWO/THREE PLUS FAMILY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CORDIS 13F CATHETER SHEATH INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code CAW·May 8, 2013

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·September 12, 2014

    ON-Q SILVERSOAKER

    FDA Adverse Event
    Injury ·I-FLOW CORP.·Product code MEB·May 19, 2011

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 31, 2021

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 31, 2021

    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

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    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

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020