BEUDAMED
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    XPAND CORPECTOMY SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074195544·PROXIMAL SCREW 8.5 X 50, TI

    3D

    FDA UDI
    Rmo, Inc.·00885797100245·WILSON TOOL KIT

    Cortera Spinal Fixation System

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311209828·Tap, Solid, Iliac, 8.5

    NA

    FDA UDI
    Summit Medical, Inc.·00385640001359·

    POLESTAR N-10

    FDA 510(k)
    FDA Class 2 ·Radiology

    GPF-29 GENERAL PURPOSE COIL SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    G7 FINNED LTD HOLE CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·October 25, 2017

    G7 ARCOMXL POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·October 25, 2017

    G7 E1 POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·October 25, 2017

    G7 HI-WALL ARCOMXL LNR 36MM F M F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·October 25, 2017

    G7 FINNED LTD HOLE CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·October 25, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 10, 2013

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 4, 2011

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code KFM·February 29, 2016

    Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

    GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0204-01 Otological Ventilation Tubes, Catalog Number VT-0204-01, Shepard, 1.0 mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0406-01 Otological Ventilation Tubes, Catalog Number VT-0406-01, T-Tube, 5mm x 4mm x 1.14mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-01 Otological Ventilation Tubes, Catalog Number VT-0503-01, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-50 Otological Ventilation Tubes, Catalog Number VT-0503-50, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0507-01 Otological Ventilation Tubes, Catalog Number VT-0507-01, Armstrong Grommet w/wire, 1.14mm Lumen, FL, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT0508-50 Otological Ventilation Tubes, Catalog Number VT-0508-50, Modified Armstrong Grommet 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1002-50 Otological Ventilation Tubes, Catalog Number VT-1002-50, Collar Button, 1.27mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1035-01 Otological Ventilation Tubes, Catalog Number VT-1035-01, Collar Button, 1.5mm Lumen, Titanium, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT1204-01 Otological Ventilation Tubes, Catalog Number VT-1204-01, Reuter Bobbin 1.14mm , Lumen, FL Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1421-01 Otological Ventilation Tubes, Catalog Number VT-1421-01, Angled Tab Bobbin 1.27mm Lumen, TI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. ET-ABGDT-45 Distributed By API Anthony products, Inc., ET-ABGDT-45 Armstrong Grommet, 1.14mm Lumen, FP Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-GTST-45-12, Distributed By API Anthony products, Inc., ET-GTST-45-12, T-tube 12 x 10, 1.14mm Lumen, SI , Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-SPDT-40T, Distributed By API Anthony products, Inc., ET-SPDT-40T Shea Parasol w/Tab, 1.0mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-TBDT-45 Distributed By API Anthony products, Inc., ET-TBDT-45 Reuter Bobbin w/c Holes 1.14mm Lumen, FP, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes.

    FDA Recall
    Terminated ·Micromedics, Inc.·Product code ETD·March 15, 2010