BEUDAMED
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    HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

    FDA 510(k)
    FDA Class 2 ·Neurology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032337·Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs A...

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120323371·Diamond, flame, COOL DIAMANT, coarse grit, gree...

    BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 29, 2011

    CODMAN DISPOSABLE PERFORATOR

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code HBF·April 22, 2008

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MMDX34CM RIGHT FEM IM NAIL 13MMDX34CM RIGHT FEM IM NAIL 14MMDX34CM RIGHT FEM IM NAIL 11MMDX36CM LEFT FEM IM NAIL 12MMDX36CM LEFT FEM IM NAIL 13MMDX36CM LEFT FEM IM NAIL 14MMDX36CM LEFT FEM IM NAIL 11MMDX36CM RIGHT FEM IM NAIL 12MMDX36CM RIGHT FEM IM NAIL 13MMDX36CM RIGHT FEM IM NAIL 14MMDX36CM RIGHT FEM IM NAIL 10MMDX38CM LEFT FEM IM NAIL 11MMDX38CM LEFT FEM IM NAIL 12MMDX38CM LEFT FEM IM NAIL 13MMDX38CM LEFT FEM IM NAIL 14MMDX38CM LEFT FEM IM NAIL 10MMDX38CM RIGHT FEM IM NAIL 11MMDX38CM RIGHT FEM IM NAIL 12MMDX38CM RIGHT FEM IM NAIL 13MMDX38CM RIGHT FEM IM NAIL 14MMDX38CM RIGHT FEM IM NAIL 10MMDX40CM LEFT FEM IM NAIL 11MMDX40CM LEFT FEM IM NAIL 12MMDX40CM LEFT FEM IM NAIL 13MMDX40CM LEFT FEM IM NAIL 14MMDX40CM LEFT FEM IM NAIL 10MMDX40CM RIGHT FEM IM NAIL 11MMDX40CM RIGHT FEM IM NAIL 12MMDX40CM RIGHT FEM IM NAIL 13MMDX40CM RIGHT FEM IM NAIL 14MMDX40CM RIGHT FEM IM NAIL 10MMDX42CM LEFT FEM IM NAIL 11MMDX42CM LEFT FEM IM NAIL 12MMDX42CM LEFT FEM IM NAIL 13MMDX42CM LEFT FEM IM NAIL 14MMDX42CM LEFT FEM IM NAIL 10MMDX42CM RIGHT FEM IM NAIL 11MMDX42CM RIGHT FEM IM NAIL 12MMDX42CM RIGHT FEM IM NAIL 13MMDX42CM RIGHT FEM IM NAIL 14MMDX42CM RIGHT FEM IM NAIL 10MMDX44CM LEFT FEM IM NAIL 11MMDX44CM LEFT FEM IM NAIL 12MMDX44CM LEFT FEM IM NAIL 13MMDX44CM LEFT FEM IM NAIL 14MMDX44CM LEFT FEM IM NAIL 10MMDX44CM RIGHT FEM IM NAIL 11MMDX44CM RIGHT FEM IM NAIL 12MMDX44CM RIGHT FEM IM NAIL 13MMDX44CM RIGHT FEM IM NAIL 14MMDX44CM RIGHT FEM IM NAIL 10MMDX46CM LEFT FEM IM NAIL 11MMDX46CM LEFT FEM IM NAIL 12MMDX46CM LEFT FEM IM NAIL 13MMDX46CM LEFT FEM IM NAIL 14MMDX46CM LEFT FEM IM NAIL 10MMDX46CM RIGHT FEM IM NAIL 11MMDX46CM RIGHT FEM IM NAIL 12MMDX46CM RIGHT FEM IM NAIL 13MMDX46CM RIGHT FEM IM NAIL 14MMDX46CM RIGHT FEM IM NAIL 10MMDX48CM LEFT FEM IM NAIL 11MMDX48CM LEFT FEM IM NAIL 12MMDX48CM LEFT FEM IM NAIL 13MMDX48CM LEFT FEM IM NAIL 10MMDX48CM RIGHT FEM IM NAIL 11MMDX48CM RIGHT FEM IM NAIL 12MMDX48CM RIGHT FEM IM NAIL 13MMDX48CM RIGHT FEM IM NAIL 10MMDX50CM LEFT FEM IM NAIL 11MMDX50CM LEFT FEM IM NAIL 12MMDX50CM LEFT FEM IM NAIL 13MMDX50CM LEFT FEM IM NAIL 10MMDX50CM RIGHT FEM IM NAIL 11MMDX50CM RIGHT FEM IM NAIL 12MMDX50CM RIGHT FEM IM NAIL 13MMDX50CM RIGHT

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    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