BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    Klassic Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551001448·Ear Curette, blunt, size 0

    MINIATURE BARRAQUER NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896074606·MINIATURE BARRAQUER NEEDLE HOLDER WITHOUT LOCK ...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111049446·SKLHN METZ SCISS SMO CVD 7"

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304221949·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100295·FRANKEL INFANT EYE SPECULUM

    MINIATURE BARRAQUER NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896074576·MINIATURE BARRAQUER NEEDLE HOLDER WITHOUT LOCK ...

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 21, 2023

    CRYONIZE TM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VASCON ROAMER MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025

    FREESTYLE PRECISION NEO H

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

    ENRHYTHM

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code NVZ·June 8, 2013

    MEMBRAGEL

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code NPK·June 30, 2011

    ASIAN IMHS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code JDS·September 9, 2008

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 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