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    REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Richard Wolf GmbH·04055207013922·FIBER LIGHT CABLE Ø 2.5MM TL 2.3M

    PALABOND

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DXTEND GLENOSPHERE STD D42MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE·Product code KWS·December 6, 2012

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·April 16, 2013

    THE CLOSER S 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·April 8, 2008

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 12, 2011

    RX HERCULINK 14 PLUS STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA·Product code FGE·December 10, 2010

    RX HERCULINK 14 PLUS STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA·Product code FGE·December 10, 2010

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 13 MML X 3.5 MMP

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 17, 2021

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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