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calendar

2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 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: 1 catalyst2026-07-25: 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: 0 catalysts2026-09-02: 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 filing2,387
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings294
  • therapy area

    no tagged catalysts yet

    Week of Sep 8, 2025

    28
    ›Sep 10, 2025device pma317d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma317d 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 ↗
    ›Sep 10, 2025device pma317d agoABBOTT MEDICAL — CardioMEMSTM HF System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma317d agoBeaver Visitec International, Inc. — FINEVISION HP Trifocal IOLs (PMA)

    Product code: HQL. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Sep 10, 2025device pma317d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma317d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma317d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma317d agoBiosense Webster, Inc. — VARIPULSE™ Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma317d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Multifocal 3-Piece IOL (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma317d agoMedtronic Neuromodulation — InterStim® Therapy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 11, 2025device pma316d agoBiotronik, Inc. — Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 11, 2025device pma316d agoRecor Medical, Inc. — ReCor Paradise™ Catheter (PMA supplement)VYCOR MEDICAL INC

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

    full page →fda device pma ↗
    ›Sep 11, 2025device pma316d 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 (4071 (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 11, 2025device pma316d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 11, 2025device pma316d agoRenata Medical, Inc. — Minima Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 11, 2025device pma316d agoBiotronik, Inc. — Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 11, 2025device pma316d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Odyssey IOL with TECNIS SIMPLICITY Delivery System (DRN00V); TECNIS Odyssey Toric II IOLs with TECNIS SIMPLICITY (PMA supplement)JOHNSON & JOHNSON

    Supplement type: Real-Time Process. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d agoCordis US Corporation — S.M.A.R.T.® CONTROL® Vascular Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d agoCordis US Corporation — S.M.A.R.T.® CONTROL® Nitinol Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d agoAtrium Medical Corp. — iCast Covered Stent System (PMA supplement)Apyx Medical Corp

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

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d agoTerumo Medical Corporation — MISAGO® RX Self-expanding Peripheral Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d agoMedtronic Minimed, Inc. — MiniMed 780G System (PMA supplement)Medtronic USA Inc

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

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d 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 ↗
    ›Sep 12, 2025device pma315d agoBerlin Heart, Inc. — EXCOR Cannula Clip (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: DSQ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d agoLivaNova USA, Inc. — VNS Therapy® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d agoEdwards Lifesciences, LLC — Edwards EVOQUE tricuspid delivery system (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Sep 12, 2025device pma315d 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 ↗
    ›Sep 12, 2025device pma315d agoMedtronic Minimed — Simplera System (PMA supplement)

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

    full page →fda device pma ↗

    Week of Sep 15, 2025

    22
    ›Sep 15, 2025device pma312d agoBiotronik, Inc. — Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma
    ← prev
    page 15 of 40
    next →
    312d ago
    Medtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoAbiomed, Inc. — Purge Cassette (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoMedtronic Vascular — Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d 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; Enitr (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d 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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoAbiomed, Inc. — Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoBiotronik, Inc. — Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Ilivia 7 DF4 VR-T 40462 (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoBausch and Lomb, Inc., — ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoBiotronik, Inc. — Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoBiosense Webster, Inc. — SMARTABLATE™ System Interface Cable (D-1303-02-S) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoMedtronic Neuromodulation — Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoGeneoscopy, Inc. — ColoSense® (PMA supplement)

    Supplement type: Real-Time Process. Product code: SBB. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma312d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific Corp — ACC SUP SUTURE SLEEVE; ACC SUP FLUSHING TOOL; ACC WRENCH TORQUE-BI; ACC SUP LD CAP LV1 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific — ACC SUP CONNECTOR QUAD PSA TO IS4; ACC SUP SUTURE SLEEVE; ACC SUP KIT LD CAP; STRL PKG LEAD REPAIR KIT; ACC STY STR .016 (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific — ACC SUP PLUG (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific — ACC WRENCH (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Sep 16, 2025device pma311d agoBoston Scientific Corporation — SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    $APYX
    $EW91.33-2.47%
    $JNJ259.27+1.42%
    $JNJ259.27+1.42%
    $JNJ259.27+1.42%
    $MDT82.01+0.15%
    $VYCO0.06600.00%
    $MDT82.01+0.15%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $BSX43.58+1.42%
    $BSX43.58+1.42%