Calendar

Week of Sep 29, 2025

Oct 3, 2025device 510k331d agoMagentiq Eye, Ltd. — MAGENTIQ-COLO (ME-APDS) (510k cleared)

Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

Oct 3, 2025device 510k331d agoHollister Incorporated — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) (510k cleared)

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

full page →fda device 510k ↗

Oct 3, 2025device 510k331d agoRevolve Surgical, Inc. — Revolve Surgical System (510k cleared)

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

full page →fda device 510k ↗

Oct 3, 2025device 510k331d agoSenbitec Co., Ltd. — HESTIA (L200-A) (510k cleared)

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

full page →fda device 510k ↗

Oct 3, 2025device 510k331d agoBunkerHill Health — Bunkerhill MAC (510k cleared)

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

full page →fda device 510k ↗

Oct 3, 2025device 510k331d agoAlleva Medical Devices — extriCARE® 1000 Negative Pressure Wound Therapy System (510k cleared)

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

full page →fda device 510k ↗

Oct 3, 2025device 510k331d agoJeisys Medical Incorporated — TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) (510k cleared)

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

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Oct 3, 2025device 510k331d agoHealthhub — HPACS (510k cleared)

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

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Oct 3, 2025device 510k331d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

full page →fda device 510k ↗

Oct 3, 2025device 510k331d agoABBOTT MEDICAL — Amplatzer Guidewire (510k cleared)

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

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Oct 3, 2025device 510k331d agoInternacional Farmacéutica S.A DE C.V — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) (510k cleared)

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

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Oct 3, 2025device 510k331d agoDongguan Yiyao Science & Technology Development Co., Ltd. — Anti Snore Mouthpiece (510k cleared)

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

full page →fda device 510k ↗

Oct 3, 2025device 510k331d agoAugmedics, Ltd. — xvision Spine system (510k cleared)

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

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Oct 3, 2025device 510k331d agoIcecure Medical — ProSense System (510k cleared)IceCure Medical Ltd.

Product code: QXW. Advisory committee: General, Plastic Surgery. Type: Direct

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Oct 3, 2025device 510k331d agoTosoh Bioscience, Inc. — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (510k cleared)BJ Bioscience Inc

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

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Oct 3, 2025device 510k331d agoSmith & Nephew, Inc. — AETOS Shoulder System Stemless Humeral Prosthesis (510k cleared)SMITH & NEPHEW PLC

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

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Oct 3, 2025device 510k331d agoOlympus Medical Systems Corporation — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (510k cleared)

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

full page →fda device 510k ↗

Oct 3, 2025device pma331d agoNyxoah S.A. — Genio® System 2.1 (PMA supplement)Nyxoah SA

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

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Oct 3, 2025device pma331d agoMedtronic, Inc. — Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra (PMA supplement)Medtronic plc

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

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Oct 3, 2025device pma331d agoMedtronic, Inc. — Aurora EV ICD (DVEA3E4) (PMA supplement)Medtronic plc

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

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Oct 3, 2025device pma331d agoEBR Systems, Inc. — WiSE (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

Supplement type: Special (Immediate Track). Product code: SEG. Advisory committee: CV. Decision: APPR

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Oct 3, 2025device pma331d agoQIAGEN GmbH — QIAGEN therascreen® FGFR RGQ RT-PCR Kit (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: OWD. Advisory committee: MG. Decision: APPR

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Oct 3, 2025device pma331d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

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

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Oct 3, 2025device pma331d agoAlcon Research, Ltd. — PROVISC Ophthalmic Viscosurgical Device (PMA supplement)Rubicon Research Ltd

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

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Oct 3, 2025device pma331d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRTD DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI CR (PMA supplement)

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

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Oct 3, 2025device pma331d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

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

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Oct 3, 2025device pma331d agoUromedica, Inc. — ProACT Adjustable Continence Therapy for Men (PMA supplement)

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

full page →fda device pma ↗

Oct 3, 2025device pma331d agoAlcon Laboratories — VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (PMA supplement)Alcon Laboratories Inc

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

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Oct 3, 2025device pma331d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (PMA supplement)

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

full page →fda device pma ↗

Oct 3, 2025device pma331d agoMedtronic, Inc. — Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 3, 2025device recall331d agoMedtronic Perfusion Systems device recall (Cls II)

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo — Reason: As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout. — Status: Ongoing

full page →fda device recalls ↗

Oct 3, 2025device recall331d agoMedline Industries, LP device recall (Cls II)

MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. — Reason: Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals. — Status: Ongoing

full page →fda device recalls ↗

Oct 3, 2025device recall331d agoIntegra LifeSciences Corp. (NeuroSciences) device recall (Cls II)INTEGRA LIFESCIENCES HOLDINGS CORP

TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; — Reason: It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy. — Status: Ongoing

full page →fda device recalls ↗

Oct 4, 2025approval330d agoZORYVE (ROFLUMILAST) — FDA approvalArcutis Biotherapeutics, Inc.

Sponsor: ARCUTIS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Oct 4, 2025device pma330d agoABBOTT MEDICAL — Tendyne Transcatheter Mitral Valve System (PMA supplement)

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

full page →fda device pma ↗

Week of Oct 6, 2025

Oct 6, 2025approval328d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Oct 6, 2025approval

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