Calendar

Week of Feb 2, 2026

Feb 3, 2026device 510k190d agoMedtronic Minimed — SmartGuard Technology; Predictive Low Glucose Technology (510k cleared)

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

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Feb 3, 2026device 510k190d agoUlrich Medical USA, Inc. — Navigation Module of the Cortium® System (510k cleared)

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

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Feb 3, 2026device 510k190d agoXi'An Taibo Electronic Technology Co., Ltd. — 808nm semiconductor laser hair removal machine (510k cleared)

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

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Feb 3, 2026device 510k190d agoDexcom, Inc. — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (510k cleared)DEXCOM INC

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

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Feb 3, 2026device 510k190d agoMedacta International S.A. — MSS - Monobloc stem (510k cleared)Stemedica International S.A.

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

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Feb 3, 2026device pma190d agoGen-Probe Incorporated — Aptima HPV 16 18/45 Genotype Assay (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: OYB. Advisory committee: MI. Decision: APPR

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Feb 3, 2026device pma190d agoBiotronik, Inc. — PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (PMA supplement)

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

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Feb 3, 2026device pma190d agoABBOTT MEDICAL — TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T (PMA supplement)

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

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Feb 3, 2026device pma190d agoGen-Probe Incorporated — APTIMA HPV ASSAY (PMA supplement)

Supplement type: Panel Track. Product code: OYB. Advisory committee: MI. Decision: APPR

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Feb 3, 2026device pma190d agoAbbott — CentriMag Circulatory Support System (PMA supplement)

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

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Feb 3, 2026device pma190d agoBiotronik, Inc. — PHYLAX AV ICD SYSTEM (PMA supplement)

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

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Feb 3, 2026device pma190d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (PMA supplement)Edwards Lifesciences Corp

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

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Feb 3, 2026device pma190d agoBiotronik, Inc. — DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (PMA supplement)

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

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Feb 3, 2026device pma190d agoAbbott Vascular — XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine), XIENCE Sierra Everolimus Eluting Coronary Stent (PMA supplement)Postsurgical Therapeutics Inc

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

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Feb 3, 2026device pma190d agoBiotronik, Inc. — TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (PMA supplement)

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

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Feb 3, 2026device pma190d agoBiotronik, Inc. — STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (PMA supplement)

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

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Feb 3, 2026device pma190d agoMedtronic — HeartWare® HVAD System (PMA supplement)Medtronic plc

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

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Feb 3, 2026device recall190d agoExactech, Inc. device recall (Cls II)

Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 — Reason: Impactor handle may be missing cross-pin — Status: Ongoing

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Feb 3, 2026device recall190d agoGE Medical Systems, LLC device recall (Cls II)

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP — Reason: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. — Status: Ongoing

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Feb 3, 2026device recall190d agoExactech, Inc. device recall (Cls II)

Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X — Reason: Impactor handle may be missing cross-pin — Status: Ongoing

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Feb 3, 2026device recall190d agoIon Beam Applications S.A. device recall (Cls II)

IBA Proton Therapy System - PROTEUS 235 — Reason: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used. — Status: Ongoing

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Feb 3, 2026grant190d agoUNIVERSITY OF PENNSYLVANIA — SHIV-infected rhesus macaques as a model for HIV-1 bNAb developmentUniversity of Pennsylvania

AI grant. $803,591. PI: GEORGE M SHAW

Week of Feb 2, 2026