BEUDAMED
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    DUREPAIR DURA REGENERATION MATRIX

    FDA 510(k)
    FDA Class 2 ·Neurology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809849509·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE EXTRA LA...

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00852979003670·Pierse Corneal Fcps, Straight, Titanium

    EFILM WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 31, 2010

    NUVASIVE

    FDA Adverse Event
    Injury ·NUVASIVE·Product code NKB·January 10, 2011

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018

    NEXUS AND NXT DETACHABLE COIL

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code HCG·January 16, 2009

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 9, 2013

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·April 12, 2011

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·May 21, 2008

    NEXUS AND NXT DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code HCG·April 21, 2009

    Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09 FA-71350-25V16 FA-71400-25V10 FA-71425-35V13 FA-71475-30V16 FA-71300-25V12 FA-71350-25V17 FA-71400-25V11 FA-71425-35V15 FA-71475-30V18 FA-71300-25V13 FA-71350-25V18 FA-71400-25V12 FA-71425-35V18 FA-71475-35V09 FA-71300-25V15 FA-71350-25V19 FA-71400-25V13 FA-71450-25V09 FA-71475-35V10 FA-71300-25V16 FA-71350-30V09 FA-71400-25V15 FA-71450-25V10 FA-71475-35V11 FA-71300-25V17 FA-71350-30V10 FA-71400-25V16 FA-71450-25V11 FA-71475-35V12 FA-71300-25V18 FA-71350-30V12 FA-71400-25V18 FA-71450-25V12 FA-71475-35V13 FA-71300-25V19 FA-71350-30V13 FA-71400-25V19 FA-71450-25V13 FA-71475-35V15 FA-71300-30V09 FA-71350-30V15 FA-71400-30V09 FA-71450-25V15 FA-71475-35V18 FA-71300-30V12 FA-71350-30V16 FA-71400-30V10 FA-71450-25V16 FA-71475-35V19 FA-71300-30V13 FA-71350-30V18 FA-71400-30V11 FA-71450-25V18 FA-71500-25V09 FA-71300-30V15 FA-71350-35V09 FA-71400-30V12 FA-71450-25V19 FA-71500-25V10 FA-71300-30V16 FA-71350-35V10 FA-71400-30V13 FA-71450-30V09 FA-71500-25V11 FA-71300-30V19 FA-71350-35V12 FA-71400-30V15 FA-71450-30V10 FA-71500-25V12 FA-71300-35V09 FA-71350-35V13 FA-71400-30V16 FA-71450-30V11 FA-71500-25V13 FA-71300-35V12 FA-71350-35V15 FA-71400-30V18 FA-71450-30V12 FA-71500-25V15 FA-71300-35V13 FA-71350-35V18 FA-71400-35V09 FA-71450-30V13 FA-71500-25V16 FA-71300-35V15 FA-71375-25V09 FA-71400-35V13 FA-71450-30V15 FA-71500-25V18 FA-71325-25V09 FA-71375-25V10 FA-71400-35V15 FA-71450-30V16 FA-71500-25V19 FA-71325-25V10 FA-71375-25V11 FA-71400-35V18 FA-71450-30V18 FA-71500-30V09 FA-71325-25V12 FA-71375-25V12 FA-71425-25V09 FA-71450-30V19 FA-71500-30V10 FA-71325-25V13 FA-71375-25V13 FA-71425-25V10 FA-71450-35V09 FA-71500-30V11 FA-71325-25V15 FA-71375-25V15 FA-71425-25V11 FA-71450-35V10 FA-71500-30V12 FA-71325-25V18 FA-71375-25V16 FA-71425-25V12 FA-71450-35V12 FA-71500-30V13 FA-71325-25V19 FA-71375-25V17 FA-71425-25V13 FA-71450-35V13 FA-71500-30V15 FA-71325-30V09 FA-71375-25V18 FA-71425-25V15 FA-71450-35V15 FA-71500-30V16 FA-71325-30V10 FA-71375-25V19 FA-71425-25V16 FA-71450-35V16 FA-71500-30V17 FA-71325-30V12 FA-71375-30V09 FA-71425-25V18 FA-71475-25V09 FA-71500-30V18 FA-71325-30V13 FA-71375-30V10 FA-71425-25V19 FA-71475-25V10 FA-71500-35V09 FA-71325-30V15 FA-71375-30V12 FA-71425-30V09 FA-71475-25V11 FA-71500-35V10 FA-71325-30V16 FA-71375-30V13 FA-71425-30V10 FA-71475-25V12 FA-71500-35V11 FA-71325-30V18 FA-71375-30V15 FA-71425-30V11 FA-71475-25V13 FA-71500-35V12 FA-71325-30V19 FA-71375-30V16 FA-71425-30V12 FA-71475-25V15 FA-71500-35V13 FA-71325-35V09 FA-71375-30V18 FA-71425-30V13 FA-71475-25V16 FA-71500-35V15 FA-71325-35V12 FA-71325-35V13 FA-71325-35V15 FA-71350-25V09 FA-71350-25V10 FA-71350-25V13 FA-71350-25V15 FA-77250-10V13 FA-77250-10V19 FA-77250-12V11 FA-77250-12V12 FA-77250-12V13 FA-77250-12V18 FA-77250-14V12 FA-77250-14V13 FA-77250-14V15 FA-77250-14V18 FA-77250-14V19 FA-77250-16V11 FA-77250-16V12 FA-77250-16V13 FA-77250-16V15 FA-77250-16V16 FA-77250-16V19 FA-77250-18V09 FA-77250-18V10 FA-77250-18V11 FA-77250-18V12 FA-77250-18V13 FA-77250-18V16 FA-77250-18V18 FA-77250-18V19 FA-77250-20V10 FA-77250-20V11 FA-71375-35V09 FA-71375-35V12 FA-71375-35V13 FA-71375-35V15 FA-71375-35V16 FA-71375-35V18 FA-71400-25V09 FA-77275-14V11 FA-77275-14V12 FA-77275-14V13 FA-77275-14V17 FA-77275-14V18 FA-77275-14V19 FA-77275-16V12 FA-77275-16V13 FA-77275-16V16 FA-77275-16V18 FA-77275-16V19 FA-772

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90. 9. Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20. 10. Posterior Column Plate, Left; Article Numbers: 212121-6. 11. Posterior Column Plate, Right; Article Numbers: 212131-6. 12. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM. 13. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA. 14. Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM. 15. Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8. 16. Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8. 17. PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7. 18. Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13. 19. Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11. 20. Rim Plate, Left; Article

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026