Calendar

Week of Jan 12, 2026

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

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing

full page →fda recalls ↗

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

full page →fda recalls ↗

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

full page →fda recalls ↗

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

full page →fda recalls ↗

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

full page →fda recalls ↗

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

full page →fda device 510k ↗

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

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

full page →fda device 510k ↗

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

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

full page →fda device 510k ↗

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

full page →fda device 510k ↗

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

full page →fda device 510k ↗

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

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

full page →fda device 510k ↗

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

full page →fda device 510k ↗

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

full page →fda device 510k ↗

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

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

full page →fda device 510k ↗

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

full page →fda device pma ↗

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

full page →fda device pma ↗

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

full page →fda device pma ↗

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

full page →fda device pma ↗

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

full page →nih reporter ↗

Jan 15, 2026approval209d agoOSELTAMIVIR PHOSPHATE — FDA approvalOSELTAMIVIR PHOSPHATE

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

full page →OSELTAMIVIR PHOSPHATE →fda approvals ↗

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

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

full page →belumosudil mesylate →fda approvals ↗

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