Calendar

Week of Sep 8, 2025

Sep 10, 2025recall355d agoB BRAUN MEDICAL INC recall (Cls I)B. Braun Medical Inc

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07 — Reason: Presence of Particulate Matter — Status: Ongoing

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Sep 10, 2025recall355d agoIMMUNOCORE, LLC recall (Cls II)Immunocore Holdings plc

KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026 — Reason: Subpotent Drug — Status: Ongoing

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Sep 10, 2025recall355d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

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Sep 10, 2025device 510k355d agoMerit Medical System, Inc. — Surfacer Inside-Out Access Catheter System (510k cleared)MERIT MEDICAL SYSTEMS INC

Product code: QJH. Advisory committee: Cardiovascular. Type: Special

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Sep 10, 2025device 510k355d agoMr Surgical Solutions, LLC — OptiVu Shoulder (510k cleared)

Product code: SBF. Advisory committee: Neurology. Type: Special

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Sep 10, 2025device 510k355d agoFisher & Paykel Healthcare, Ltd. — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full (510k cleared)

Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional

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Sep 10, 2025device 510k355d agoBeckman Coulter, Inc. — iQ200 Series (510k cleared)

Product code: LKM. Advisory committee: Hematology. Type: Special

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Sep 10, 2025device 510k355d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Sep 10, 2025device 510k355d agoVizionfocus, Inc. — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

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Sep 10, 2025device 510k355d agoAngiowave Imaging, Inc. — AngioWaveNet (510k cleared)

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

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Sep 10, 2025device 510k355d agoPollogen, Ltd. — OptiLUV Device (510k cleared)

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

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Sep 10, 2025device 510k355d agoTimpel S.A. — Enlight 2100 (TPL-E2103-0) (510k cleared)TIM S.A.

Product code: QEB. Advisory committee: Anesthesiology. Type: Traditional

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Sep 10, 2025device pma355d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Foldable Acrylic IOL with OptiEdge (PMA supplement)JOHNSON & JOHNSON

Supplement type: Normal 180 Day Track No User Fee. Product code: HQL. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma355d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: APPR

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Sep 10, 2025device pma355d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30

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Sep 10, 2025device pma355d agoABBOTT MEDICAL — CardioMEMSTM HF System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30

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Sep 10, 2025device pma355d agoBeaver Visitec International, Inc. — FINEVISION HP Trifocal IOLs (PMA)

Product code: HQL. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma355d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

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Sep 10, 2025device pma355d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

Supplement type: Panel Track. Product code: MAQ. Advisory committee: MI. Decision: APPR

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Sep 10, 2025device pma355d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (PMA supplement)JOHNSON & JOHNSON

Supplement type: Normal 180 Day Track No User Fee. Product code: HQL. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma355d agoBiosense Webster, Inc. — VARIPULSE Catheter (PMA supplement)

Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30

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Sep 10, 2025device pma355d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Multifocal 3-Piece IOL (PMA supplement)JOHNSON & JOHNSON

Supplement type: Normal 180 Day Track No User Fee. Product code: MFK. Advisory committee: OP. Decision: APPR

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Sep 10, 2025device pma355d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: APPR

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