Calendar

Week of Jan 12, 2026

Jan 14, 2026recall210d agoSpecGx, LLC recall (Cls II)SpecGx LLC

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493 — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing

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Jan 14, 2026recall210d agoSignature Formulations, LLC recall (Cls II)

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing

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Jan 14, 2026recall210d agoAvKARE recall (Cls II)AvKare LLC

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15 — Reason: Out of specification for dissolution. — Status: Ongoing

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Jan 14, 2026recall210d agoAlembic Pharmaceuticals Limited recall (Cls III)Alembic Pharmaceuticals Inc

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30 — Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. — Status: Ongoing

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Jan 14, 2026recall210d agoImprimis NJOF, LLC recall (Cls II)OCULAR THERAPEUTIX, INC

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing

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Jan 14, 2026recall210d agoImprimis NJOF, LLC recall (Cls II)OCULAR THERAPEUTIX, INC

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1 — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing

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Jan 14, 2026device 510k210d agoSync Surgical — Cervical Interbody and VBR Fusion System (510k cleared)

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

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Jan 14, 2026device 510k210d agoZiehm-Orthoscan, Inc. — Orthoscan TAU MVP Mini C-Arm System (510k cleared)

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

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Jan 14, 2026device 510k210d agoMeticuly Co., Ltd. — METICULY Patient-specific titanium mesh implant (510k cleared)

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

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Jan 14, 2026device 510k210d agoPhilips Medical Systems Nederland B.V. — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T (510k cleared)

Product code: MOS. Advisory committee: Radiology. Type: Special

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Jan 14, 2026device 510k210d agoCardinalhealth — Cardinal Health Nitrile Examination Gloves Extended Cuff (510k cleared)CARDINAL HEALTH INC

Product code: LZC. Advisory committee: General Hospital. Type: Traditional

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Jan 14, 2026device 510k210d agoBrainlab SE — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (510k cleared)

Product code: IYE. Advisory committee: Radiology. Type: Special

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Jan 14, 2026device 510k210d agoMedtronic Minimed, Inc. — SmartGuard technology; Predictive Low Glucose technology (510k cleared)Medtronic USA Inc

Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional

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Jan 14, 2026device 510k210d agoLaboratorios Biogalenic S.A. DE C.V. — Laboratorios Biogalenic Sterile Water for Inhalation, USP (510k cleared)

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

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Jan 14, 2026device 510k210d agoMedtronic, Inc. — Concerto Versa Detachable Coil (510k cleared)Medtronic plc

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

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Jan 14, 2026device 510k210d agoEntire Medical , Ltd. — ENTire IRE System (510k cleared)

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

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Jan 14, 2026device pma210d agoTeoxane S.A. — RHA® Redensity dermal filler (PMA supplement)

Supplement type: Special (Immediate Track). Product code: LMH. Advisory committee: SU. Decision: APPR

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Jan 14, 2026device pma210d agoCardiovascular Systems, Inc. — Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MCX. Advisory committee: CV. Decision: APPR

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Jan 14, 2026device pma210d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: SDL. Advisory committee: AN. Decision: OK30

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Jan 14, 2026device pma210d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

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Jan 14, 2026device pma210d agoMedtronic Neuromodulation — InterStim Therapy System, Verify Evaluation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

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Jan 14, 2026device pma210d agoAdvanced Medical Solutions Limited — LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (PMA supplement)

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

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Jan 14, 2026device pma210d agoMedtronic Neuromodulation — InterStim Therapy System, Verify Evaluation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

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Jan 14, 2026device pma210d agoMedtronic Neuromodulation — Altaviva (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30

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Jan 14, 2026device pma210d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

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Jan 14, 2026device recall210d agoEdermy LLC device recall (Cls II)

PIE PAK Models: P2HC-A, P2HC-S, P2HC — Reason: Lack of 510K clearance — Status: Ongoing

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Jan 14, 2026device recall210d agoEdermy LLC device recall (Cls II)

PIE Trolley System Model: 2005 — Reason: Lack of 510K clearance — Status: Ongoing

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Jan 14, 2026grant210d agoLOUISIANA STATE UNIV A&M COL BATON ROUGE — Role of host glutaminolysis in tuberculosis pathogenesis

GM grant. $196,875. PI: Stephania A Cormier

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Jan 15, 2026approval209d agoOSELTAMIVIR PHOSPHATE — FDA approvalOSELTAMIVIR PHOSPHATE

Sponsor: AJANTA PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

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Jan 15, 2026approval209d agoREZUROCK (BELUMOSUDIL MESYLATE) — FDA approvalbelumosudil mesylate

Sponsor: KADMON PHARMS LLC. Form: TABLET. Route: ORAL

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Jan 15, 2026approval209d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC