BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569936·CoRoent Ant TLIF Ti, 12x13x30mm 0°

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551001288·Sickle Knife, slightly curved

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702655438·ELVAREX FORTE 3/THIGH HIGH/OPEN TOE/DOTTED SILI...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04059993108084·ELVAREX 1/THIGH HIGH/CLOSED TOE/DOTTED 2,5 CM S...

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113995·Votion .022 MC LR3 -6T 3A 0O (10PK) VOTION

    Pinnacle

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730010131·Pinnacle .022 MC LR3 -6T 3A 0O (10PK)

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730008305·Votion .022 MC LR3 -6T 3A 0O (10PK)

    Pinnacle®

    FDA UDI
    Ortho Organizers, Inc.·00190707112080·Pinnacle .022 MC LR3 -6T 3A 0O (10PK) PINNACLE

    Marquis

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730012531·Marquis MBT 022 LR3 Rx -6 Tor +3 Ang (10PK)

    HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 20, 2012

    UNKNOWN ZIMMER TM ANKLE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSN·October 29, 2014

    CELL-DYN 3700 SL ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 25, 2011

    EXTENSION SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 12, 2013

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 8, 2019

    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

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018