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calendar

1,317 catalysts · 4,648 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,502 device recall · 1,317 device pma

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type: device pma×from 2025-09-06×clear all
type
  • grant4,648
  • 8k filing3,603
  • approval2,587
  • device 510k1,903
  • device recall1,502
  • device pma1,317
device adverse event
1,000
  • earnings585
  • recall534
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Sep 1, 2025

    2
    ›Sep 7, 2025device pma357d agoABBOTT MEDICAL — Liberta RC™ DBS IPG (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MHY. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Sep 7, 2025device pma357d agoABBOTT MEDICAL — Eterna™ SCS IPG (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗

    Week of Sep 8, 2025

    43
    ›Sep 8, 2025device pma356d agoFerrosan Meidcal Devices A/S — SURGIFOAM® Absorbable Gelatin Sponge (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Sep 8, 2025device pma

    Week of Sep 15, 2025

    5
    ›Sep 15, 2025device pma349d 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 1 of 27
    next →
    356d ago
    Croma-Pharma GmbH — saypha® MagIQ™ (PMA)

    Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Sep 8, 2025device pma356d agoOrganox Limited — OrganOx metra® System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoIntegra Lifesciences Corp. — INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

    Supplement type: 30-Day Notice. Product code: MGR. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoETHICON, Inc. — SURGICEL BRAND ABSORBABLE HEMOSTAT (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoMedtronic Cardiac Rhythm Disease Management — Cardiac Resynchronization Therapy -Defibrillator (CRT-D) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoEdwards Lifesciences, LLC — PASCAL Precision Transcatheter Valve Repair System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Iliac Branch Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoWomed Sas — Womed Leaf Resorbable Adhesion Barrier (PMA)

    Product code: MCN. Advisory committee: OB. Decision: APPR

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d agoMedtronic Cardiac Rhythm Disease Management — Implantable Cardioverter Defibrillator (ICD) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 9, 2025device pma355d 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 ↗
    ›Sep 9, 2025device pma355d agoW. L. Gore & Associates, Inc. — Conformable GORE® TAG® Thoracic Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 10, 2025device pma354d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Foldable Acrylic IOL with OptiEdge (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 pma354d 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 pma354d 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 pma354d 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 pma354d 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 pma354d 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 pma354d 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 pma354d 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 pma354d 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 pma354d 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 pma354d 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 pma353d 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 pma353d 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 pma353d 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 pma353d 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 pma353d 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 pma353d 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 pma353d 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 pma352d 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 pma352d 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 pma352d 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 pma352d 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 pma352d 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 pma352d 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 pma352d 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 pma352d 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 pma352d 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 pma352d 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 pma352d agoMedtronic Minimed — Simplera System (PMA supplement)

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

    full page →fda device pma ↗
    349d 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 pma349d 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 pma349d 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 pma349d 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 ↗
    $JNJ268.04+0.85%
    $EW91.33-2.47%
    $APYX
    $JNJ268.04+0.85%
    $JNJ268.04+0.85%
    $VYCO0.06600.00%
    $EW91.33-2.47%
    $MDT91.23+1.40%
    $JNJ268.04+0.85%
    $IART16.85-0.18%
    $MDT91.23+1.40%