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Week of Mar 2, 2026

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Mar 3, 2026device 510k168d agoHarrison-AI Medical Pty, Ltd. — Annalise Enterprise (510k cleared)

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

full page →fda device 510k ↗

Mar 3, 2026device 510k168d agoTHINK Surgical, Inc. — TMINI® Miniature Robotic System (510k cleared)

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

full page →fda device 510k ↗

Mar 3, 2026device 510k168d agoSota Cloud Corp. — SOTA Cloud Smart Sensor (1.5) (510k cleared)

Product code: MUH. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Mar 3, 2026device 510k168d agoHaidari Beauty Technology (Beijing) Co., Ltd. — CO2 Laser Treatment Machine (CFR3M1) (510k cleared)

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

full page →fda device 510k ↗

Mar 3, 2026device 510k168d agoArthrex, Inc. — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (510k cleared)

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

full page →fda device 510k ↗

Mar 3, 2026device 510k168d agoNew Stetic, SA — ZAFIRA® (510k cleared)

Product code: EBF. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Mar 3, 2026device 510k168d agoShenzhen Hanhua Opto Co., Ltd. — LED Therapy Light (COB1400, HP1800PRO) (510k cleared)

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

full page →fda device 510k ↗

Mar 3, 2026device 510k168d agoPremier Dental Products Company — Bond-PR Universal Adhesive (510k cleared)

Product code: KLE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Mar 3, 2026device pma168d agoMedtronic, Inc. — Mosaic Neo Mitral Bioprosthesis (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: DYE. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Mar 3, 2026device pma168d agoPerimeter Medical Imaging Ai, Inc. — Claire OCT System (PMA)

Product code: SHH. Advisory committee: SU. Decision: APPR

full page →fda device pma ↗

Mar 3, 2026device pma168d agoMedtronic, Inc. — HexaGen RF Generator (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Mar 3, 2026device pma168d agoValencia Technologies Corporation — eCoin Peripheral Neurostimulator (PMA supplement)

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

full page →fda device pma ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15 OR Table; System Code: 722059; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 5 M12; System Code: (1)722227, (2)722231; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall168d agoOxoid Australia Pty Limited device recall (Cls II)THERMO FISHER SCIENTIFIC INC.

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem — Reason: Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells. — Status: Ongoing

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Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10F; System Code: 722002; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/10; System Code: 722029; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20 OR Table; System Code: 722039; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15; System Code: 722058; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20; System Code: 722038; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10C; System Code: 722001; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

full page →fda device recalls ↗

Mar 3, 2026device recall168d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026grant168d agoVANDERBILT UNIVERSITY — Transcranial Functional Ultrasound in Adult Humans

EB grant. $542,947. PI: Brett C Byram

full page →nih reporter ↗

Mar 3, 2026grant168d agoUNIVERSITY OF MISSISSIPPI — Ionic liquid-assisted drug delivery to brain reservoirs for treatment of neur...

DA grant. $101,214. PI: Jason Richard Paris

full page →nih reporter ↗

Mar 3, 2026grant168d agoGORDON RESEARCH CONFERENCES — 2026 Immunoengineering Gordon Research Conference and Gordon Research Seminar

AI grant. $19,000. PI: Nicole Franziska Steinmetz

full page →nih reporter ↗

Mar 3, 2026grant168d agoKEYSTONE SYMPOSIA — RNA Modifications: Bridging Biological Function and Therapeutic Potential

CA grant. $10,000. PI: TERRY L. SHEPPARD

full page →nih reporter ↗

Mar 3, 2026grant168d agoMAYO CLINIC ROCHESTER — Acute Kidney Injury in Care Transitions: The ACT Pragmatic TrialMayo Clinic

DK grant. $796,370. PI: Erin Frazee Barreto

full page →nih reporter ↗

Mar 3, 2026grant168d agoKEYSTONE SYMPOSIA — Cancer Immunotherapy: Basic Mechanisms Informing Clinical Applications & Comb...

CA grant. $5,000. PI: TERRY L. SHEPPARD

full page →nih reporter ↗

Mar 3, 2026grant168d agoMICHIGAN STATE UNIVERSITY — Probing nucleolus function in a mouse model of fragile X syndrome

MH grant. $416,859. PI: Hongbing Wang

full page →nih reporter ↗

Mar 3, 2026grant168d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Functional RNA elements in the human genomeUniversity of California San Diego

HG grant. $785,329. PI: Kevin Daniel Corbett

full page →nih reporter ↗

Mar 4, 2026approval167d agoBAL (DIMERCAPROL) — FDA approvalAkorn Operating Company LLC (Inactive)

Sponsor: PROVEPHARM SAS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 4, 2026approval167d agoROCURONIUM BROMIDE — FDA approvalROCURONIUM BROMIDE

Sponsor: ASPIRO. Form: INJECTABLE. Route: INJECTION

full page →ROCURONIUM BROMIDE →fda approvals ↗

Mar 4, 2026approval167d agoEMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE) — FDA approvalHetero USA Inc

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 4, 2026approval167d agoCALCITONIN-SALMON (CALCITONIN SALMON) — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 4, 2026approval167d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL

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Mar 4, 2026approval167d agoGLIPIZIDE — FDA approvalGraviti Pharmaceuticals Inc

Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 4, 2026recall167d agoWizcure Pharmaa Private Limited recall (Cls II)

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

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