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

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    Maven Patient-Specific Instrumentation

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    10M - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

    Conventional Lead Apron .5mm Xtra Large 25 X 40

    FDA UDI
    Flow X Ray Corporation·00843696123628·Conventional Lead Apron .5mm Xtra Large 25 X 40...

    10PW - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020129·10PW - General Purpose

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112526·BARRON VACUUM TREPHINE 8.25MM

    RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERIFIX CATHETER CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LAPAROSCOPIC PACK (LADCA)144

    FDA Adverse Event
    Injury ·MEX03 MEXICO-JUAREZ PRESOURCE·Product code LRO·February 18, 2020

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 29, 2015

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011

    AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·June 27, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2014

    GORE HELEX SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MLV·January 7, 2020

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·May 16, 2019

    Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·May 16, 2019

    Cepheid Xpert C. difficile/Epi Control Panel

    FDA Recall
    Open, Classified ·Microbiologics Inc·Product code PMN·May 16, 2019