Calendar

Week of Nov 17, 2025

Nov 17, 2025device recall276d agoETAC A/S device recall (Cls II)

Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. — Reason: A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment. — Status: Ongoing

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Nov 17, 2025device recall276d agoETAC A/S device recall (Cls II)

Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover. — Reason: A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment. — Status: Ongoing

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Nov 17, 2025grant276d agoUNIVERSITY OF CALIFORNIA BERKELEY — Site-Selective C-H Borylation Directed by Noncovalent Interactions

GM grant. $74,632. PI: Jingyi Luo

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Nov 17, 2025grant276d agoEMORY UNIVERSITY — The Nerve of Chemo: Unpacking Chemotherapy-Induced Peripheral Neuropathy in B...Emory University

NR grant. $49,538. PI: La-Urshalar Beaushenique Brock

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Nov 17, 2025grant276d agoPURDUE UNIVERSITY — Determining the Role of csoS2 in Carboxysome Assembly and Regulation

GM grant. $75,052. PI: Kristy Rochon

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Nov 18, 2025approval275d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

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Nov 18, 2025approval275d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

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Nov 18, 2025approval275d agoDICHLORPHENAMIDE — FDA approvalDICHLORPHENAMIDE

Sponsor: RISING. Form: TABLET. Route: ORAL

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Nov 18, 2025approval275d agoTAMSULOSIN HYDROCHLORIDE — FDA approvalTAMSULOSIN HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: CAPSULE. Route: ORAL

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Nov 18, 2025approval275d agoFLUPHENAZINE HYDROCHLORIDE — FDA approvalFLUPHENAZINE HYDROCHLORIDE

Sponsor: HETERO LABS LTD III. Form: TABLET. Route: ORAL

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Nov 18, 2025approval275d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

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Nov 18, 2025approval275d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

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Nov 18, 2025approval275d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

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Nov 18, 2025approval275d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

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Nov 18, 2025approval275d agoSUPREP BOWEL PREP KIT (MAGNESIUM SULFATE) — FDA approvalMAGNESIUM SULFATE

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

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Nov 18, 2025approval275d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

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Nov 18, 2025approval275d agoREDEMPLO (PLOZASIRAN SODIUM) — FDA approvalplozasiran sodium

Sponsor: ARROWHEAD. Form: SOLUTION. Route: SUBCUTANEOUS

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Nov 18, 2025device 510k275d agoGuangzhou Wondfo Biotech Co., Ltd. — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx (510k cleared)

Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

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Nov 18, 2025device 510k275d agoCollagen Matrix, Inc. — Collagen Dura Regeneration Membrane - Repair (510k cleared)

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

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Nov 18, 2025device 510k275d agoUlrich GmbH & Co. KG — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (510k cleared)

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

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Nov 18, 2025device 510k275d agoDouble Medical Technology, Inc. — Universal Spinal System (510k cleared)

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

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Nov 18, 2025device 510k275d agoNvision Biomedical Technologies, Inc. — ToeJack MIS Bunion System (510k cleared)

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

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Nov 18, 2025device 510k275d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) (510k cleared)

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

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Nov 18, 2025device 510k275d agoPrismatik Dentalcraft, Inc. — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems (510k cleared)

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

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Nov 18, 2025device 510k275d agoKarl Storz SE & CO. KG — Miniature Telescope for Urology (27033AA) (510k cleared)

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

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Nov 18, 2025device 510k275d agoSuretex Limited — LifeStyles® HydraFeel Natural Rubber Latex Condom (510k cleared)

Product code: HIS. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated

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Nov 18, 2025device 510k275d agoDexcom, Inc. — Dexcom Smart Basal (510k cleared)DEXCOM INC

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

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Nov 18, 2025device 510k275d agoThe Surgical Company International B.V. — Fluido Compact System (510k cleared)

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

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Nov 18, 2025device 510k275d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) (510k cleared)

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

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Nov 18, 2025device 510k275d agoCarre Technologies, Inc. — Hexoskin Medical System (7100-00016) (510k cleared)Q/C TECHNOLOGIES, INC.

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

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Nov 18, 2025device pma275d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (PMA supplement)

Supplement type: Real-Time Process. Product code: MVK. Advisory committee: CV. Decision: APPR

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Nov 18, 2025device pma275d agoPhilips Image Guided Therapy Corporation — Duo Venous Stent System (PMA supplement)

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

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Nov 18, 2025device pma275d agoMentor Worldwide, LLC — MENTOR Saline-Filled and SPECTRUM Breast Implants (PMA supplement)Revalesio Corp

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

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Nov 18, 2025device recall275d agoInstrumentation Laboratory device recall (Cls III)

HemosIL SynthAFax. Partial Thromboplastin Time Tests. — Reason: Recalled lots were manufactured with double the amount of preservative concentration. — Status: Ongoing

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Nov 18, 2025device recall275d agoMindray DS USA, Inc. dba Mindray North America device recall (Cls II)

Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1) — Reason: When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. — Status: Ongoing

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Nov 18, 2025device recall275d agoAGFA Healthcare Corp. device recall (Cls II)TENET HEALTHCARE CORP

Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 — Reason: It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled. — Status: Ongoing

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Nov 18, 2025device recall275d agoDICOM Grid, Inc. device recall (Cls II)

Intelerad InteleShare software, with ProViewer component — Reason: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up. — Status: Ongoing

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Nov 18, 2025grant275d agoCASE WESTERN RESERVE UNIVERSITY — Olfactory Phenotypes as Non-Invasive Biomarkers for Alzheimer's Disease: A Ma...Case Western Reserve University

AG grant. $746,114. PI: Jennifer Villwock

full page →nih reporter ↗

Nov 19, 2025approval274d agoEYLEA HD (AFLIBERCEPT) — FDA approvalEYLEA HD

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →EYLEA HD →fda approvals ↗

Nov 19, 2025approval274d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

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Nov 19, 2025approval274d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL

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Nov 19, 2025approval274d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

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Nov 19, 2025approval274d agoNILOTINIB HYDROCHLORIDE — FDA approvalNILOTINIB HYDROCHLORIDE

Sponsor: HETERO LABS LTD V. Form: CAPSULE. Route: ORAL

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Nov 19, 2025approval274d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Nov 19, 2025approval274d agoIMDELLTRA (TARLATAMAB-DLLE) — FDA approvaltarlatamab

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

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Nov 19, 2025approval274d agoNILOTINIB HYDROCHLORIDE — FDA approvalHetero Labs Ltd

Sponsor: DR REDDYS. Form: CAPSULE. Route: ORAL

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Nov 19, 2025approval274d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗

Nov 19, 2025approval274d agoIGALMI (DEXMEDETOMIDINE HYDROCHLORIDE) — FDA approvaldexmedetomidine

Sponsor: BIOXCEL. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →dexmedetomidine →fda approvals ↗

Nov 19, 2025approval274d agoNILOTINIB HYDROCHLORIDE — FDA approvalNILOTINIB HYDROCHLORIDE

Sponsor: MSN. Form: CAPSULE. Route: ORAL

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Nov 19, 2025approval274d agoKOSELUGO (SELUMETINIB SULFATE) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

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Week of Nov 17, 2025