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calendar

19,619 catalysts · 4,728 grant · 3,062 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma

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2026-08-10: 0 catalysts2026-08-11: 33 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 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: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 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: 2 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: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • grant4,728
  • 8k filing3,062
  • device 510k2,785
  • approval2,724
  • device recall2,000
  • device pma1,962
device adverse event
1,000
  • recall693
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 2, 2025

    50
    ›Jun 4, 2025device pma433d agoDiaSorin, Inc. — LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma433d agoDiaSorin, Inc. — LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma433d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 4, 2025device pma433d agoSiemens Corp. — ADVIA Centaur HBsAgII (HBsII) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 4, 2025device 510k433d agoPhilips Medical Systems Nederland B.V. — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (510k cleared)

    Product code: LNH. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoId Korea Co., Ltd. — ID LIGHT CURE SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoOlympus Medical Systems Corporation — Disposable Balloon Catheter B5-2C (510k cleared)

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoPhyscade, Inc. — PhysCade System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoMedifield Medical Co., Ltd. — Montblanc Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoNg Biotech — NG-Test® CTX-M MULTI (510k cleared)

    Product code: PTJ. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoJkh Health Co., Ltd. — Ultrasound Stimulator (510k cleared)

    Product code: IMI. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoWeero Co., Ltd. — EVE Synergy (EVE-20M) (510k cleared)

    Product code: IPF. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoSurgify Medical OY — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (510k cleared)

    Product code: HBE. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoBarbaras Development, Inc. — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (510k cleared)

    Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoSk Zen, LLC — LubriZenzs (510k cleared)

    Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoBrainlab , Ltd. — TraumaCad Neo (1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoProprio, Inc. — Paradigm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoThe ScottCare Corporation — TeleRehab Aermos Cardiopulmonary Rehabilitation (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoPromisemed Hangzhou Meditech Co., Ltd. — Blood collection tube holders (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoKerecis Limited — Tendon Protect (50242) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device pma432d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoW. L. Gore and Associates, Inc. — GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoW. L. Gore and Associates, Inc. — GORE EXCLUDER Conformable AAA Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoW. L. Gore & Associates, Inc. — 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 ↗
    ›Jun 5, 2025device pma432d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoMedtronic, Inc. — CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® AAA Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d 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 ↗
    ›Jun 5, 2025device pma432d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoMedtronic, Inc. — CapSureFix MRI Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DVPB3D1; Cobalt XT MRI ICD DDPA2D1; Cobalt XT MRI ICD DVPA2D1; Crome MRI ICD DDPC (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoNuvasive, Inc. — Simplify® Cervical Artificial Disc (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d 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 ↗
    ›Jun 5, 2025device pma432d agoCeramtec GmbH — Ceramic TRANSCEND® Hip Articulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d 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 ↗
    ›Jun 5, 2025device pma432d agoBiosense Webster, Inc. — VARIPULSE Bi-Directional Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 5, 2025device pma432d agoMedtronic — HeartWare™ Ventricular Assist System (HVAD) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 5, 2025device 510k432d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — Portable Oxygen Concentrator (Spirit-3) (510k cleared)

    Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoPhilips DS North America, LLC — UroNav 4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoGrumpy Innovation, Inc. — Portare System (FA-001) (510k cleared)

    Product code: EOB. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoEstetic Ceram AG — zirkon; structure; LFU shades, stains and glazes (510k cleared)

    Product code: EIH. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoCorin U.S.A. Limited — Trinity EVO Acetabular Shell (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoNihon Kohden Digital Health Solutions, LLC — Central Station (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoIcu Medical, Inc. — Clave™ Neutral-Displacement Needlefree Connectors (510k cleared)ICU MEDICAL INC/DE

    Product code: FPA. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoOlympus Medical Systems Corp. — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoShenzhen Idea Light Limited — Red Light Hair Growth Cap (LP-RJVGRW-BLK) (510k cleared)

    Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoDeepHealth, Inc. — TechLive (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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