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Week of Nov 24, 2025

23

Nov 28, 2025approval263d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

full page →EPYSQLI →fda approvals ↗

Nov 28, 2025approval263d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Nov 28, 2025approval263d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Nov 28, 2025approval263d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Nov 28, 2025approval263d agoCYCLOSPORINE — FDA approvalRestasis

Sponsor: AMNEAL. Form: EMULSION. Route: OPHTHALMIC

full page →Restasis →fda approvals ↗

Nov 28, 2025approval263d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 28, 2025approval263d agoARMLUPEG (PEGFILGRASTIM-UNNE) — FDA approvalARMLUPEG

Sponsor: LUPIN LTD. Form: INJECTION. Route: SOLUTION

full page →ARMLUPEG →fda approvals ↗

Nov 28, 2025device 510k263d agoBaoding Te'Anzhou Electronic Technology Co., Ltd. — Medical Diode Laser Systems (TR-B) (510k cleared)

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

full page →fda device 510k ↗

Nov 28, 2025device 510k263d agoDendrite Imaging, Inc. — Dendrite Imaging System (510k cleared)

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

full page →fda device 510k ↗

Nov 28, 2025device 510k263d agoSophysa — Sophy Mini Monopressure Valve (SM1) (510k cleared)

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

full page →fda device 510k ↗

Nov 28, 2025device 510k263d agoCanon Medical Informatics, Inc. — CT VScore+ (510k cleared)

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

full page →fda device 510k ↗

Nov 28, 2025device pma263d agoCleveland Diagnostics, Inc. — IsoPSA Assay (PMA)Co-Diagnostics, Inc.

Product code: QRF. Advisory committee: IM. Decision: APPR

full page →fda device pma ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoBaxter Healthcare Corporation device recall (Cls II)Baxter Healthcare Corp

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 — Reason: Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 28, 2025device recall263d agoRAYSEARCH LABORATORIES AB device recall (Cls II)

RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System — Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. — Status: Ongoing

full page →fda device recalls ↗

Nov 29, 2025device recall262d agoHANGZHOU BEVER MEDICAL DEVICES CO., LTD. device recall (Cls II)

BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F — Reason: Labeling error, Incorrect expiration date — Status: Ongoing

full page →fda device recalls ↗

Week of Dec 1, 2025

27

Dec 1, 2025approval260d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 1, 2025approval

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