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    ROGOSA BROTH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SOL-M™ Luer Lock Syringe with Exchangeable Needle

    FDA UDI
    Sol-Millennium Medical, Inc.·00818392010107·Used to inject medicines and vaccines into, or ...

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707034849·.019 X .025 Upper Econo Nickel Titanium Archwires

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102374·BARRAQUER IRIS SPATULA 0.25MM

    ASCOT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 10, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2012

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    FDA Adverse Event
    Malfunction ·PLEXUS MANUFACTURING SDN. BHD·Product code DTE·June 10, 2015

    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024