BEUDAMED
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    YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030771·Basin Set, Cent Double

    Mini Unicycle™

    FDA UDI
    Ortho Organizers, Inc.·00190707056698·Mini Unicycle™ .120” Ligature Ties - Clear

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707009634·CALIBRA 1ST MOLAR BANDS n.UR 26

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319720295·DeBakey Atraumatic Tissue Forceps, 2.0mm wide t...

    MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022

    THREE PEG PATELLA 32MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 30, 2024

    LOGIC TIBIA PS MOD INSRT SZ 3 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 30, 2024

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 9, 2013

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·September 26, 2014

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·June 10, 2011

    ROOT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·September 20, 2018

    HANG&GO HT BASIC

    FDA Adverse Event
    Malfunction ·RAND S.R.L.·Product code LGZ·May 15, 2017

    Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. 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. 510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.

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

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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