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Week of Oct 6, 2025

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Oct 9, 2025device pma310d agoEndologix, LLC — DETOUR System (PMA supplement)

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

full page →fda device pma ↗

Oct 9, 2025device pma310d agoMedtronic Cardiac Rhythm Disease Management — MEDTRONIC SELECTSECURE LEAD MODEL 3830 (PMA supplement)

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

full page →fda device pma ↗

Oct 9, 2025device pma310d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗

Oct 9, 2025device pma310d agoMedtronic Minimed, Inc. — Guardian 4 Sensor (PMA supplement)Medtronic USA Inc

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

full page →fda device pma ↗

Oct 9, 2025device pma310d agoIntrinsic Therapeutics — Barricaid® Annular Closure Device (PMA supplement)Insignis Therapeutics Inc

Supplement type: Normal 180 Day Track. Product code: QES. Advisory committee: OR. Decision: APPR

full page →fda device pma ↗

Oct 9, 2025device pma310d agoRayner Intraocular Lenses , Ltd. — RayOne EMV Toric (PMA supplement)

Supplement type: Panel Track. Product code: HQL. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗

Oct 9, 2025device pma310d agoMedtronic Minimed — Guardian Connect System (PMA supplement)

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

full page →fda device pma ↗

Oct 9, 2025device pma310d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis (PMA supplement)

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

full page →fda device pma ↗

Oct 9, 2025device recall310d agoMyofunctional Research Company USA device recall (Cls II)

Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers: — Reason: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. — Status: Ongoing

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Oct 9, 2025device recall310d agoThoratec LLC device recall (Cls II)

Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 LVAS — Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. — Status: Ongoing

full page →fda device recalls ↗

Oct 9, 2025device recall310d agoB-K Medical A/S device recall (Cls II)

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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 recall310d agoB-K Medical A/S device recall (Cls II)

bk5000 Ultrasound System w/battery; Model No. 2300-61; 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

full page →fda device recalls ↗

Oct 9, 2025device recall310d agoB-K Medical A/S device recall (Cls II)

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; 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 recall310d agoThoratec LLC device recall (Cls II)

Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The HeartMate II System Controller is a small computer that controls and monitors system operation. It sends power and operating signals to the Left Ventricular Assist Device and adjusts device operation to maintain programmed levels of cardiac support. The System Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records device performance and alarm data, and transfers the information to the HeartMate Touch Communication System. Component: Yes, HeartMate II¿ LVAS Implant Kit — Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. — Status: Ongoing

full page →fda device recalls ↗

Oct 9, 2025device recall310d agoGlycar SA Pty., Ltd. device recall (Cls I)

SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE — Reason: The impacted lot may not meet the required tensile strength specification. — Status: Ongoing

full page →fda device recalls ↗

Oct 9, 2025device recall310d agoThoratec LLC device recall (Cls II)Volt Lithium Corp.

Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries. 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

full page →fda device recalls ↗

Oct 9, 2025device recall310d agoPivotal Health Solutions, Inc. device recall (Cls II)SRx Health Solutions, Inc.

Quantum Intersegmental Table, Model/Catalog Number: Q400; 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

full page →fda device recalls ↗

Oct 9, 2025device recall310d agoB-K Medical A/S device recall (Cls II)

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; 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

full page →fda device recalls ↗

Oct 9, 2025device recall310d agoB-K Medical A/S device recall (Cls II)

bk3000 Ultrasound System w/battery; Model No. 2300-66; 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

full page →fda device recalls ↗

Oct 9, 2025device recall310d agoGlycar SA Pty., Ltd. device recall (Cls I)

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE — Reason: The impacted lot may not meet the required tensile strength specification. — Status: Ongoing

full page →fda device recalls ↗

Oct 9, 2025device recall310d 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

full page →fda device recalls ↗

Oct 9, 2025device recall310d 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 recall310d 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

full page →fda device recalls ↗

Oct 9, 2025device recall310d 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

full page →fda device recalls ↗

Oct 9, 2025grant310d 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, 2025approval309d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

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Oct 10, 2025approval309d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

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Oct 10, 2025approval309d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 10, 2025approval309d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2025approval309d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Oct 10, 2025approval309d agoERRIN (NORETHINDRONE) — FDA approvalNaari USA Inc

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

full page →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoUNITUXIN (DINUTUXIMAB) — FDA approvalUNITED THERAPEUTICS Corp

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

full page →fda approvals ↗

Oct 10, 2025approval309d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

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

full page →fda approvals ↗

Oct 10, 2025approval309d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

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

full page →fda approvals ↗

Oct 10, 2025approval309d agoGALLIUM GA 68 EDOTREOTIDE (GALLIUM GA-68 EDOTREOTIDE) — FDA approval

Sponsor: METHODIST. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 10, 2025approval309d agoRINVOQ LQ (UPADACITINIB) — FDA approvalupadacitinib

Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL

full page →upadacitinib →fda approvals ↗

Oct 10, 2025approval309d agoONGENTYS (OPICAPONE) — FDA approvalopicapone

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →opicapone →fda approvals ↗

Oct 10, 2025approval309d agoOLPRUVA (SODIUM PHENYLBUTYRATE) — FDA approvalSODIUM PHENYLBUTYRATE

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

full page →SODIUM PHENYLBUTYRATE →fda approvals ↗

Oct 10, 2025approval309d agoCHLORPROMAZINE HYDROCHLORIDE — FDA approvalFosun Pharma USA Inc

Sponsor: RUBICON. Form: CONCENTRATE. Route: ORAL

full page →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Oct 10, 2025approval309d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMicro Labs Ltd

Sponsor: UMEDICA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Oct 10, 2025approval309d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

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