Calendar

Week of Oct 6, 2025

Oct 9, 2025device recall309d agoThoratec LLC device recall (Cls II)

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No — Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. — Status: Ongoing

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Oct 9, 2025device recall309d agoB-K Medical A/S device recall (Cls II)

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing

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Oct 9, 2025device recall309d agoC-RAD POSITIONING AB device recall (Cls II)

Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable — Reason: Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance. — Status: Ongoing

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Oct 9, 2025device recall309d agoPivotal Health Solutions, Inc. device recall (Cls II)SRx Health Solutions, Inc.

Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table — Reason: The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion. — Status: Ongoing

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Oct 9, 2025grant309d agoUNIVERSITY OF NEW MEXICO — Advancing precision medicine through measurement of reward and relief drinking

AA grant. $39,309. PI: Hanna Marie Hebden

full page →nih reporter ↗

Oct 10, 2025approval308d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

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Oct 10, 2025approval308d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

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Oct 10, 2025approval308d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

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Oct 10, 2025approval308d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2025approval308d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2025approval308d agoERRIN (NORETHINDRONE) — FDA approvalNaari USA Inc

Sponsor: DR REDDYS LABS SA. Form: TABLET. Route: ORAL-28

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Oct 10, 2025approval308d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoUNITUXIN (DINUTUXIMAB) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS

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Oct 10, 2025approval308d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

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Oct 10, 2025approval308d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

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Oct 10, 2025approval308d agoGALLIUM GA 68 EDOTREOTIDE (GALLIUM GA-68 EDOTREOTIDE) — FDA approval

Sponsor: METHODIST. Form: SOLUTION. Route: INTRAVENOUS

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Oct 10, 2025approval308d agoRINVOQ LQ (UPADACITINIB) — FDA approvalupadacitinib

Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL

full page →upadacitinib →fda approvals ↗

Oct 10, 2025approval308d agoONGENTYS (OPICAPONE) — FDA approvalopicapone

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →opicapone →fda approvals ↗

Oct 10, 2025approval308d agoOLPRUVA (SODIUM PHENYLBUTYRATE) — FDA approvalSODIUM PHENYLBUTYRATE

Sponsor: ACER. Form: FOR SUSPENSION. Route: ORAL

full page →SODIUM PHENYLBUTYRATE →fda approvals ↗

Oct 10, 2025approval308d agoCHLORPROMAZINE HYDROCHLORIDE — FDA approvalFosun Pharma USA Inc

Sponsor: RUBICON. Form: CONCENTRATE. Route: ORAL

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Oct 10, 2025approval308d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

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Oct 10, 2025approval308d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMicro Labs Ltd

Sponsor: UMEDICA. Form: TABLET. Route: ORAL

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Oct 10, 2025approval308d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval308d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →upadacitinib tartrate ER →fda approvals ↗

Oct 10, 2025device 510k308d agoDev4 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (510k cleared)

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

full page →fda device 510k ↗

Oct 10, 2025device 510k308d agoEvoEndo, Inc. — EvoEndo Single-Use Endoscopy System (510k cleared)

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

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Oct 10, 2025device 510k308d agoDegen Medical — DeGen Medical Latitude-C AM Cervical Interbody Fusion System (510k cleared)

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

full page →fda device 510k ↗

Oct 10, 2025device 510k308d agoGold Standard Diagnostics, LLC — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (510k cleared)

Product code: GMQ. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗

Oct 10, 2025device 510k308d agoOlympus Medical Systems Corporation — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (510k cleared)

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

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Oct 10, 2025device 510k308d agoSolventum US, LLC — Tegaderm Post-Op Transparent Antimicrobial Dressing (510k cleared)

Product code: FRO. Advisory committee: Unknown. Type: Traditional

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Oct 10, 2025device 510k308d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

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Oct 10, 2025device 510k308d agoSoclean, Inc. — SoClean 3+ (510k cleared)

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

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Oct 10, 2025device 510k308d agoACON Laboratories, Inc. — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (510k cleared)Alcon Laboratories Inc

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

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Oct 10, 2025device 510k308d agoOsseofuse International, Inc. — HexaPLUS S OneDrill Implant System (510k cleared)ICF International, Inc.

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

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Oct 10, 2025device 510k308d agoZeta Surgical, Inc. — Zeta Navigation System (ZNS131-US) (510k cleared)

Product code: SGE. Advisory committee: Neurology. Type: Special

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Oct 10, 2025device 510k308d agoProcept Biorobotics — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (510k cleared)PROCEPT BioRobotics Corp

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

full page →fda device 510k ↗

Oct 10, 2025device 510k308d agoWinner Medical Co., Ltd. — Collagen Wound Dressing (510k cleared)

Product code: KGN. Advisory committee: Unknown. Type: Traditional

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Oct 10, 2025device 510k308d agoFoshan Jindi Electric Appliance Co., Ltd. — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) (510k cleared)

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

full page →fda device 510k ↗

Oct 10, 2025device 510k308d agoCryosurgery, Inc. — Verruca-Freeze H Plus (510k cleared)

Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗

Oct 10, 2025device 510k308d agoCanon Medical Systems Corporation — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (510k cleared)

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

full page →fda device 510k ↗

Oct 10, 2025device 510k308d agoNeocis, Inc. — Yomi Robotic System (510k cleared)

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

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Oct 10, 2025device pma308d agoDiaSorin, Inc. — LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 10, 2025device pma308d agoDiaSorin, Inc. — LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 10, 2025device pma308d agoMedtronic, Inc. — DiamondTemp Ablation System (PMA supplement)Medtronic plc

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

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Week of Oct 6, 2025