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    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE , Catalog Number: POHFSPMH1; 62) KIT, SPINE , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·January 22, 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