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

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    SYNTHES LCP PEDIATRIC PLATE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...

    N/A

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000033330·PROSTHESIS 1112085 H/A TOTAL 90 OFF RND

    NA

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490033350·PROSTHESIS 1112085 H/A TOTAL 90 OFF RND

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006076·7200 2WAY NRBV GIANT 2OD"

    16PW - PG&E - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588120850·16PW - PG&E - Poly White

    Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837089863·

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521112085D0·12 x 85 mm Anodized SI Implant Fully Threaded

    SOMNO STAR & SERIES SLEEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    M2A-T M/H RDL SOL/SHL SZ41/66

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·July 15, 2019

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·May 7, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 2, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    M2A-TAPER LINER SZ 41/32

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDL·October 28, 2019

    32MM M2A MOD HEAD+12MM NK SKTD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDL·July 15, 2019

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    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