BEUDAMED
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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 24, 2024

    BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 26, 2025

    BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·October 18, 2023

    BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01, 111-206-01, 107-245-01, 107-246-01; BD Pyxis CII Safe, Software: V9, REF: 107-252-01, 111-215, 111-216, 111-219, 111-221. BD Pyxis CII Safe, Software: ES, REF: 107-254-01, 107-255-01, 1116-00, 1117-00; BD Pyxis CII Safe, Software: N/A, REF: 111-113, 111-114, 111-115, 111-160-201, 111-217, 111-218, 111-220, 111-222; Tripp Lite SUPER6TEL Surge Suppressor, REF: CN 200-025. Used with BD Pyxis CII Safe System: v7.x for WES7 User Guide, DIR 10000145747/ v8.1 User Guide, DIR 10000277635/v9.0 User Guide, DIR 10000354270/ ES User Guide v1.8, DIR 10000418517

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 12, 2023

    Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01], STOCKSTN V10.X WIRED SCANNER [132-52-02], PRS STOCKSTN V10.X WIRED SCANNER [132-52-01], BD Pyxis CII Safe ES Desktop PC [1156-00], BD Pyxis SupplyStation Panel PC V11 [1132-00], BD Pyxis SupplyRoller V11 [1127-00], Dell 640 Server [1128-00], BD Pyxis SupplyStation System V11 [1123-00], BD Pyxis CII Safe ES 10885403512605 [1116-00], BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00], BD Pyxis SupplyRoller V10 [1101-00], BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221], BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194], BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01], BD Pyxis SupplyStation V10 [347], BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01], BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191], BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198], BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01], BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01], BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215], BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216], BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219], Supply itParActive RF V11 (Supply Kanban) [138566-01]

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 2, 2025

    BD Pyxis CII Safe ES, REF: 1116-00

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·December 18, 2024

    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·May 17, 2023

    All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·November 5, 2025

    (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·February 19, 2025

    BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00 BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00 BD Pyxis" CIISafe, V9.X, SGL IM, BIO, / 10885403512520 / 111-221 BD Pyxis" CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO / N/A / 111-194 BD Pyxis" MedBank Tower / 10885403512568 / 169-29 BD Pyxis" CIISafe, V8.X Desktop PC, Bio / N/A / 107-245-01 Supply Server / N/A / N/A CCE Enterprise SW Site License (2-5) / N/A / N/A BD Pyxis" Logistics / N/A / 806 BD Pyxis" SupplyStation" V9 / N/A / 317 Security Module / N/A / 139698-01 Supply itParActive RF V11 / N/A / 138566-01 BD Knowledge Portal for Medication Technologies / N/A / 136607-01 STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-02 PRS STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-01 STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-02 PRS STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-01 BD Pyxis" CII Safe ES, Desktop PC / N/A / 1156-00 BD Pyxis" SupplyStation" Panel PC V11 / N/A / 1132-00 Pyxis" SupplyRoller V11 / N/A / 1127-00 Dell 640 Server / N/A / 1128-00 BD Pyxis" SupplyStation" System V11 / N/A / 1123-00 BD Pyxis" SupplyRoller V10 / N/A / 1101-00 BD Pyxis" SupplyStation" System V10 / **** / 347 BD Pyxis CII Safe,V9.X DESKTOP PC / **** / 107-252-01 BD Pyxis CII Safe,V7.X,DBL INTG MAIN,BIO,CLEAR DO 111-191 BD Pyxis CII Safe, V9.X, DBL IM, BIO, SLD DOORS / **** / 111-215 BD Care Coordination Engine (CCE) / **** / 134056-01 The Pyxis devices are automated medication dispensing cabinet that is intended to securely store and dispense medications to a qualified and authorized healthcare provider.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·September 3, 2025

    BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·December 31, 2025

    Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.-Boxborough·June 24, 2026

    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Inspire Medical Systems Inc.·June 24, 2026

    MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    FDA Enforcement
    Class II ·Ongoing·ConMed Corporation·June 24, 2026

    Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·June 24, 2026