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calendar

2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,391 8k filing · 2,000 device pma

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2026-07-20: 0 catalysts2026-07-21: 0 catalysts2026-07-22: 0 catalysts2026-07-23: 0 catalysts2026-07-24: 5 catalysts2026-07-25: 0 catalysts2026-07-26: 0 catalysts2026-07-27: 2 catalysts2026-07-28: 4 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 0 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts
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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,391
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Oct 13, 2025

    24
    ›Oct 17, 2025device pma280d agoABBOTT MEDICAL — TriClip G4 System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoW. L. Gore & Associates, Inc. — GORE® TAG® Thoracic Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoABBOTT MEDICAL — MITRACLIP DELIVERY SYSTEM (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoRoche Molecular Systems, Inc. — cobas® HBV (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoMedtronic Neuromodulation — Altaviva™ Implantable Neurostimulator (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoSiemens Healthcare Diagnostics — Atellica IM Hepatitis B core IgM (aHBcM) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoAbbott Vascular, Inc. — XACT Carotid Stent System (XACT CSS) and XACT Transcarotid Stent System (XACT TSS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoSiemens Healthcare Diagnostics — Atellica IM Hepatitis B e Antigen (HBeAg) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoSiemens Corp. — Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoBoston Scientific — RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM HBc Total 2 (HBcT2) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoBoston Scientific Corp — RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoSiemens Corp. — Atellica IM Hepatitis B surface Antigen II (HBsII) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Anti-HBe2 (aHBe2) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoBeckman Coulter, Inc. — Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (PMA)

    Product code: LOM. Advisory committee: MI. Decision: APRL

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoAbbott Molecular, Inc. — Alinity m HBV (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoABBOTT MEDICAL — HeartMate Apical Coring Knife (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 17, 2025device pma280d agoBoston Scientific Corp — RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗

    Week of Oct 20, 2025

    26
    ›Oct 21, 2025device pma276d agoCordis US Corporation — PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 21, 2025device pma
    ← prev
    page 20 of 40
    next →
    276d ago
    Medtronic Neuromodulation — Altaviva™ Implantable Neurostimulator (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 21, 2025device pma276d agoBiotronik, Inc. — Astron Peripheral Self- Expanding Nitinol Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 21, 2025device pma276d agoBiotronik, Inc. — Pulsar-18 T3 Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 21, 2025device pma276d agoInspire Medical Systems — Inspire Upper Airway Stimulation (PMA supplement)Inspire Medical Systems, Inc.

    Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoAbbott Vascular — RX Herculink Elite (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoBoston Scientific Corp — G124 MOMENTUM™ CRT-D, G125 MOMENTUM™ CRT-D, G126 MOMENTUM™ CRT-D, G128 MOMENTUM, G138 MOMENTUM™ X4 CRT-D, G140 INOGEN™ C (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoGuidant Corp. — U125 VALITUDE™ CRT-P,U128 VALITUDE™ X4 CRT-P,U225 VISIONIST™ CRT-P,U226 VISIONIST™ CRT-P,U228 VISIONIST™ X4 CRT-P (PMA supplement)Guident Corp.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoAbbott Vascular — RX Acculink (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoLife Technologies Corporation — Oncomine Dx Express Test (PMA supplement)

    Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoTransMedics, Inc. — Organ Care System™ (OCS™) Heart System (PMA supplement)TransMedics Group, Inc.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoABBOTT MEDICAL — Esprit BTK RX System; Esprit BTK OTW System (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoBoston Scientific Corp — L100 ESSENTIO™ SR,L101 ESSENTIO™ DR,L121 ESSENTIO™ EL DR,L200 PROPONENT™ SR,L201 PROPONENT™ DR,L221 PROPONENT™ EL DR,L30 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoAbbott Vascular — XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine OTW) (PMA supplement)Postsurgical Therapeutics Inc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoMedtronic, Inc. — Medtronic Evolut™ PRO+ Delivery Catheter System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoBoston Scientific — L110 ESSENTIO™ MRI SR,L111 ESSENTIO™ MRI DR,L131 ESSENTIO™ MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoLimFlow, Inc. — LimFlow System (PMA supplement)

    Supplement type: Real-Time Process. Product code: QWN. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoCook Ireland, Ltd. — Zilver Flex® 35 Vascular Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoAbbott Vascular, Inc. — Absolute Pro Vascular (PMA supplement)

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (AAP) (PMA supplement)Lifeloc Technologies, Inc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoTransMedics, Inc. — Organ Care System™ (OCS™) Lung System (PMA supplement)TransMedics Group, Inc.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoBoston Scientific — D010 INOGEN™ MINI ICD VR, D011 INOGEN™ MINI ICD VR, D012 INOGEN™ MINI ICD DR, D013 INOGEN™ MINI ICD DR, D020 DYNAGEN™ MI (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoOn-X Life Technologies, Inc. — On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (PMA supplement)Lifeloc Technologies, Inc

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoTransMedics, Inc. — Organ Care System™ (OCS™) Liver (PMA supplement)TransMedics Group, Inc.

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

    full page →fda device pma ↗
    ›Oct 22, 2025device pma275d agoBoston Scientific Corporation — A209 SICD Gen 2,A219 SICD MRI (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $INSP42.44+0.38%
    $GDNT
    $BSX43.58+1.42%
    $TMDX69.43-2.72%
    $MDT82.01+0.15%
    $BSX43.58+1.42%
    $LCTC
    $BSX43.58+1.42%
    $TMDX69.43-2.72%
    $LCTC
    $BSX43.58+1.42%
    $TMDX69.43-2.72%
    $BSX43.58+1.42%