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

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    SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Nautilus NC

    FDA UDI
    Life Spine, Inc.·00190837087180·5.5mm Rod Pusher

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104615·PS3 Screw 10.5mm x 90mm

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·June 9, 2017

    AUTOJECT 2

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AOI CRANIAL HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 11, 2011

    NEXGEN PROVISIONAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020

    SMARTSITE INFUSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·May 8, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    PURITAN BENNETT

    FDA Adverse Event
    Other ·COVIDIEN·Product code CBK·May 26, 2011

    VANGUARD MONO FINNED STM TIB 71X14

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·December 9, 2024

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·June 2, 2015

    VANGUARD ROCC TIB BRG UHMWPE 60X10MM

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·June 3, 2015

    Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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