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

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    SHENZHEN MED-LINK PULSE OXIMETER PROBE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750004805·SMAL QUEST MASK/HG GRN22ID SWL

    BIO-MODULAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304433663·

    HYLATOPICPLUS CREAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ATTUNE CR FEM RT SZ 4 CEM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code JWH·November 1, 2019

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 10, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·September 24, 2014

    EXPEDIUM SINGLE INNIE SET SCREW

    FDA Adverse Event
    Injury ·DEPUY SPINE, INC.·Product code NKB·June 2, 2011

    4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HTW·August 21, 2014

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 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

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025