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    LIFESYNC ADAPTER, MODEL LS-302

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II

    FDA UDI
    SYNERON MEDICAL LTD·37290109950359·SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II

    Australis ALIF Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215127725·

    PF4 IGG

    FDA Adverse Event
    Malfunction ·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015

    TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·April 2, 2010

    ENPULSE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 22, 2013

    OB/GYN STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·April 19, 2011

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code MMI·July 9, 2008

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 5, 2021

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025