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

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    Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing

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

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481119170·LOCATOR R-Tx Abutment For 3.0mm Platform Legacy...

    Batrik Arc Wire Brushes Reusable

    FDA UDI
    Batrik Medical Manufacturing Inc·00690521008458·Brush/Green/BD 6mm/BL 50mm/OL 45cm - Rigid - RE...

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05061075022378·KLEOS PSL METAL ROTH 022 UL2 PK5

    Verify

    FDA UDI
    SPINEOLOGY INC.·M7403150006·Verify™ Cannula & Bladder

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481129438·LOCATOR R-Tx Abutment, 3.0mm Internal Hex, Impl...

    Batrik Brush/Green/BD 6mm/BL 50mm-SNG

    FDA UDI
    Batrik Medical Manufacturing Inc·00690521008465·Brush/Green/BD 6mm/BL 50mm/OL 45cm - Rigid - SI...

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·CELT ACD VASCULAR CLOSURE DEVICE

    BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED

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

    N/A

    FDA UDI
    Zimmer, Inc.·00889024033597·

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·CELT ACD Vascular Closure Device

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·CELT ACD PLUS Vascular Closure Device

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·CELT ACD VASCULAR CLOSURE DEVICE

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·CELT ACD Vascular Closure Device

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 5, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 6, 2013

    FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MCX·August 27, 2008

    Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001

    FDA Recall
    Terminated ·Xiros Plc 28-30 Blenheim Terrace Leeds United Kingdom·Product code HXJ·May 17, 2006

    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