Calendar

Week of Dec 29, 2025

Dec 31, 2025device pma242d agoRoche Molecular Systems, Inc. — cobsa® BRAF V600 Mutation Test (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWD. Advisory committee: PA. Decision: OK30

Dec 31, 2025device recall242d agoMedline Industries, LP device recall (Cls II)

Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081 — Reason: Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication. — Status: Ongoing

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Dec 31, 2025device recall242d agoMiach Orthopaedics device recall (Cls II)

BEAR Implant. Model Number: 1000. — Reason: Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect. — Status: Ongoing

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Dec 31, 2025device recall242d agoMedica Corporation device recall (Cls II)

Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. — Reason: A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes. — Status: Ongoing

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Dec 31, 2025device recall242d agoCentinel Spine, Inc. device recall (Cls II)

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No — Reason: Products were mislabeled as the 6mm product but included the 5 mm product. — Status: Ongoing

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Dec 31, 2025grant242d agoVANDERBILT UNIVERSITY MEDICAL CENTER — Cerebral blood flow resistance mapping to identify amyloid-related imaging ab...

AG grant. $75,520. PI: Wesley T Richerson

Week of Dec 29, 2025