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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70603151·Mini-Mono-Brackets Roth 'N' .018" 9° 400 Brackets

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103150·Shaver, Closed, 15mm

    Rumor

    FDA UDI
    Ortho Organizers, Inc.·00190707003845·Rumor .018 LL4 -17T 0A 0O

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024106·Paddle Shaver, 15mm

    Rumor

    FDA UDI
    Ortho Organizers, Inc.·00190707003852·Rumor .018 LL4 HK -17T 0A 0O

    VENTRICULAR ANALYSIS TOOLKIT OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ISCREEN VISION SCREENER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HS III PROXIMAL SEAL SYTEM 4.3MM

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·April 11, 2013

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·June 13, 2008

    SYNCHRON® LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JGS·April 15, 2011

    SATELLITE SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code NVR·May 5, 2011

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 20, 2022

    BD MULTITEST¿ 6-COLOR TBNK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024

    BD MULTITEST¿ 6-COLOR TBNK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024

    Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 13, 2016

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020