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calendar

19,616 catalysts · 4,728 grant · 3,086 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma

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2026-08-10: 0 catalysts2026-08-11: 57 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 filing3,086
  • device 510k2,768
  • approval2,721
  • device recall2,000
  • device pma1,955
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 5, 2025device pma433d 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 pma433d 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 pma433d 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 pma433d 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 pma433d 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 pma433d 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 pma433d 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 pma433d 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 pma433d 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 pma433d 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 pma433d 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 pma433d 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 510k433d 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 510k433d 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 510k433d 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 510k433d 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 510k433d 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 510k433d 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 510k433d 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 510k433d 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 510k433d 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 510k433d 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 510k433d agoDeepHealth, Inc. — TechLive (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k433d agoGe Medical Systems, LLC — Sonic DL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k433d agoSynapse Biomedical, Inc. — Synchrony (20-3000) (510k cleared)RNR BioMedical Inc

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k433d agoMedtronic Navigation, Inc. — Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k433d agoBrightheart — BrightHeart View Classifier (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025approval432d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →pembrolizumab →fda approvals ↗
    ›Jun 6, 2025approval432d agoOPUVIZ (AFLIBERCEPT-YSZY) — FDA approvalOPUVIZ

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →OPUVIZ →fda approvals ↗
    ›Jun 6, 2025device pma432d agoSurmodics,Inc. — SurVeil Drug-Coated Balloon (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 6, 2025device pma432d agoNovocure, GmbH — Optune® (PMA supplement)NovoCure Ltd

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

    full page →fda device pma ↗
    ›Jun 6, 2025device pma432d agoEdwards Lifesciences, LLC — EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 6, 2025device 510k432d agoGlobus Medical, Inc. — ONVOY™ Acetabular System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoHebei JT Medical Co., Ltd. — Nd: YAG Laser Therapy System (QN-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoGeister Medizin Technik GmbH — Geister K-Rex rongeurs (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoSpine Wave, Inc. — Annex® 2 Adjacent Level System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoCreo Medical, Ltd. — SpydrBlade Flex Instrument (PRD-RG1-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoSora Neuroscience, Inc. — Cirrus Resting State fMRI Software (510k cleared)Alto Neuroscience, Inc.

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoQuanta System Spa — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoEmpatica S.r.l. — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoSi-Technology, LLC — SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (510k cleared)Singh Biotechnology LLC

    Product code: OUR. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoOmnia Medical, LLC — Omnia Medical PsiF DNA™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoTybr Health — TYBR Collagen Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoNingbo Ican Machines Co., Ltd. — Steam Sterilizer (2545D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoConvatec Limited — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (510k cleared)

    Product code: FCM. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoMBA Biotech Co., Ltd. — MBA Biotech Implant System (510k cleared)Oneness Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoMah Sing Healthcare Sdn. Bhd. — Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoCnS Medical Co., Ltd. — DELPHI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoLuminex Corporation — LIAISON PLEX Gram-Positive Blood Culture Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k432d agoSteris — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (510k cleared)STERIS plc

    Product code: FRC. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ← prev
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    $MDT90.06+0.72%
    $NVCR20.05+28.74%
    $ANRO28.61+1.13%
    $GMED79.93+1.27%
    $STE239.63+0.30%
    $MDT90.06+0.72%
    $ICUI183.41+0.54%
    $EW91.33-2.47%