Calendar

Week of Oct 13, 2025

Oct 16, 2025device pma303d agoMedtronic Minimed, Inc. — Simplera Sync Sensor, Guardian 4 Sensor (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

full page →fda device pma ↗

Oct 16, 2025device pma303d agoBiotronik, Inc. — Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 (PMA supplement)

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

full page →fda device pma ↗

Oct 16, 2025device pma303d agoFerring Pharmaceuticals, Inc. — EUFLEXXA® (1% SODIUM HYALURONATE) (PMA supplement)Ferring Pharmaceuticals Inc

Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30

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Oct 16, 2025device pma303d agoABBOTT MEDICAL — FlexAbility Ablation Catheter, Sensor Enabled (PMA supplement)

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

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Oct 16, 2025device pma303d agoMedtronic Minimed, Inc. — MiniMed 670G System; MiniMed 770G System; MiniMed 780G System (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

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Oct 16, 2025device pma303d agoBiotronik, Inc. — Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (PMA supplement)

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

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Oct 16, 2025device pma303d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

Oct 16, 2025device pma303d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES (PMA supplement)Edwards Lifesciences Corp

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

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Oct 16, 2025device pma303d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

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Oct 16, 2025device pma303d agoCarl Zeiss Meditec, Inc. — VISUMAX 800 Femtosecond Laser (PMA supplement)

Supplement type: 30-Day Notice. Product code: OTL. Advisory committee: OP. Decision: OK30

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Oct 16, 2025device pma303d agoMedtronic, Inc. — SynchroMed Infusion System, Ascenda Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

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Oct 16, 2025device pma303d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

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Oct 16, 2025device pma303d agoBiotronik, Inc. — Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H (PMA supplement)

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

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Oct 16, 2025device pma303d agoMedtronic Neuromodulation — Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Oct 16, 2025device recall303d agoCanon Medical System, USA, INC. device recall (Cls II)

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. — Reason: Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment. — Status: Ongoing

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Oct 16, 2025device recall303d agoSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION device recall (Cls II)

Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system. — Reason: Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft. — Status: Ongoing

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Oct 17, 2025approval302d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

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Oct 17, 2025approval302d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

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Oct 17, 2025approval302d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

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Oct 17, 2025approval302d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

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Oct 17, 2025approval302d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Oct 17, 2025approval302d agoGAZYVA (OBINUTUZUMAB) — FDA approvalobinutuzumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

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Oct 17, 2025approval302d agoGAZYVA (OBINUTUZUMAB) — FDA approvalobinutuzumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

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Oct 17, 2025approval302d agoBALVERSA (ERDAFITINIB) — FDA approvalerdafitinib

Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

full page →erdafitinib →fda approvals ↗

Oct 17, 2025approval302d agoTEZSPIRE (TEZEPELUMAB-EKKO) — FDA approvaltezepelumab

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →tezepelumab →fda approvals ↗

Oct 17, 2025approval302d agoHADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

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

full page →HADLIMA →fda approvals ↗

Oct 17, 2025approval302d agoCLOMIPHENE CITRATE — FDA approvalCLOMIPHENE CITRATE

Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL

full page →CLOMIPHENE CITRATE →fda approvals ↗

Oct 17, 2025approval302d agoTRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION

full page →triamcinolone acetonide Rising →fda approvals ↗

Oct 17, 2025approval302d agoBUCAPSOL (BUSPIRONE HYDROCHLORIDE) — FDA approvalBUSPIRONE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL

full page →BUSPIRONE HYDROCHLORIDE →fda approvals ↗

Oct 17, 2025approval302d agoEPIOXA HD/EPIOXA KIT (RIBOFLAVIN 5'-PHOSPHATE SODIUM) — FDA approvalriboflavin 5'-phosphate sodium

Sponsor: GLAUKOS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →riboflavin 5'-phosphate sodium →fda approvals ↗

Oct 17, 2025approval302d agoPOMALIDOMIDE — FDA approvalPOMALIDOMIDE

Sponsor: MYLAN. Form: CAPSULE. Route: ORAL

full page →POMALIDOMIDE →fda approvals ↗

Oct 17, 2025approval302d agoVYVGART (EFGARTIGIMOD ALFA) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

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Oct 17, 2025approval302d agoTACROLIMUS — FDA approvaltacrolimus ER

Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL

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Oct 17, 2025approval302d agoTACROLIMUS — FDA approvaltacrolimus ER

Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL

full page →tacrolimus ER →fda approvals ↗

Oct 17, 2025approval302d agoTACROLIMUS — FDA approvaltacrolimus ER

Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL

full page →tacrolimus ER →fda approvals ↗

Oct 17, 2025approval302d agoTACROLIMUS — FDA approvaltacrolimus ER

Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL

full page →tacrolimus ER →fda approvals ↗

Oct 17, 2025device 510k302d agoX9, Inc. — X9 Ultrasound System (510k cleared)XP Inc.

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

full page →fda device 510k ↗

Oct 17, 2025device 510k302d agoSpectrawave, Inc. — X1-FFR (510k cleared)

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

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Oct 17, 2025device 510k302d agoPhilips Medizin Systeme Boeblingen GmbH — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (510k cleared)

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

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Oct 17, 2025device 510k302d agoMedtronic Navigation, Inc. — StealthStation S8 Spine Software (510k cleared)

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

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Oct 17, 2025device 510k302d agoSureax Medical, LLC — SureAx-Guide (510k cleared)

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

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Oct 17, 2025device 510k302d agoOlympus Medical Systems Corp. — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) (510k cleared)

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

full page →fda device 510k ↗

Oct 17, 2025device 510k302d agoEndosound, Inc. — Biopsy Port Adapter (510k cleared)

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

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Oct 17, 2025device 510k302d agoCitieffe S.R.L. — Estremo Fibular Nail (510k cleared)

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

full page →fda device 510k ↗

Oct 17, 2025device 510k302d agoSiemens Healthcare Diagnostics, Inc. — ADVIA Centaur Anti-Thyroid Peroxidase II (510k cleared)Dawn Sea Therapeutics

Product code: JZO. Advisory committee: Immunology. Type: Traditional

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Oct 17, 2025device 510k302d agoShenzhen Zhenxing Ruitong Technology Co., Ltd. — MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) (510k cleared)

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

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Oct 17, 2025device 510k302d agoThe Binding Site Group , Ltd. — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (510k cleared)Dawn Sea Therapeutics

Product code: SGG. Advisory committee: Immunology. Type: Traditional

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Oct 17, 2025device 510k302d agoNeurovalens Limited — Modius Lean (510k cleared)

Product code: SFW. Advisory committee: Gastroenterology, Urology. Type: Direct

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Oct 17, 2025device 510k302d agoElectrogenics Labs, Ltd. — MOSkin Radiation Measurement System (510k cleared)

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

full page →fda device 510k ↗

Oct 17, 2025device 510k302d agoSinaptic Surgical — Osteotomy Wedge System (510k cleared)

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

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Week of Oct 13, 2025