Calendar

Week of Nov 10, 2025

Nov 13, 2025device 510k278d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Rosa® Knee System (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Traditional

Nov 13, 2025device 510k278d agoFussen Technology Co., Ltd. — Dental Computed Tomography X-ray System (510k cleared)Viomi Technology Co., Ltd

Product code: OAS. Advisory committee: Radiology. Type: Traditional

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Nov 13, 2025device 510k278d agoAtop Lighting Co., Ltd. — LED Beauty Mask (RLBXX) (510k cleared)

Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional

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Nov 13, 2025device 510k278d agoTelltale, LLC — TELLTALE Electrosurgical Guidewire System (510k cleared)

Product code: SGO. Advisory committee: Cardiovascular. Type: Traditional

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Nov 13, 2025device 510k278d agoShenzhen Future Electronic Co., Ltd. — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) (510k cleared)

Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional

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Nov 13, 2025device 510k278d agoSiemens Medical Solutions USA, Inc. — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System (510k cleared)

Product code: IYN. Advisory committee: Radiology. Type: Traditional

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Nov 13, 2025device 510k278d agoSkeletal Dynamics, Inc. — Geminus Volar Distal Radius Plating System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

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Nov 13, 2025device pma278d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: MHY. Advisory committee: NE. Decision: APPR

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Nov 13, 2025device pma278d agoMedtronic, Inc. — SynchroMed Infusion System, Ascenda Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: LKK. Advisory committee: HO. Decision: APPR

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Nov 13, 2025device pma278d agoBaxter Healthcare Corp — Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (PMA supplement)Baxter Healthcare Corp

Supplement type: 30-Day Notice. Product code: PMX. Advisory committee: SU. Decision: OK30

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Nov 13, 2025device pma278d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

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Nov 13, 2025device recall278d agoAbbott Laboratories device recall (Cls II)ABBOTT LABORATORIES

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 — Reason: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations. — Status: Ongoing

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Nov 13, 2025device recall278d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K — Reason: Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. — Status: Ongoing

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Nov 13, 2025device recall278d agoMedtronic MiniMed, Inc. device recall (Cls II)Medtronic USA Inc

InPen App, Model/CFN Number: MMT-8061 (Android Users) — Reason: When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia. — Status: Ongoing

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Nov 13, 2025device recall278d agoMedline Industries, LP device recall (Cls II)

SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 — Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized. — Status: Ongoing

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Nov 13, 2025device recall278d agoMedline Industries, LP device recall (Cls II)

FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 — Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized. — Status: Ongoing

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Nov 14, 2025approval277d agoDANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

Sponsor: AZURITY. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

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Nov 14, 2025approval277d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PFIZER. Form: TABLET. Route: ORAL

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Nov 14, 2025approval277d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

Week of Nov 10, 2025