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19,668 catalysts · 4,728 grant · 3,111 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: 82 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 filing3,111
  • 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 16, 2025

    50
    ›Jun 18, 2025device pma420d 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 429525, Ri (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma420d agoAlcon Laboratories, Inc. — AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Jun 18, 2025device pma420d 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 ↗
    ›Jun 18, 2025device pma420d agoNeomend, Inc. — PROGEL™ Pleural Air Leak Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 18, 2025device 510k420d agoShenzhen Wikkon Precision Technologies Co., Ltd. — Extracorporeal Shock Wave Lithotripter (U200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Ureteral Stents (AF-D series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoSeaSpine Orthopedics Corporation — Virata Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoAcumed, LLC — The Acumed Wrist Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoHappy Health, Inc. — Happy Health Home Sleep Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoCenterPoint Systems, LLC — FlexiGo 3D Delivery Catheter (510k cleared)

    Product code: DQY. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoFisher & Paykel Healthcare Limited — F&P Nova Nasal Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoCuriteva, Inc. — Curiteva Porous PEEK Standalone ALIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoBard Access Systems, Inc. — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoConmed Corporation — CONMED Argo Knotless® Anchor (510k cleared)CONMED Corp

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoHMC Premedical S.p.A. — Enteral Drainage System, Enteral Medicine straw (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoBioline Dental Implant Systems, Ltd. — Bioline Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoJiangxi Jiangte Electric Vehicle Co., Ltd. — Mobility Scooter (JT10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoEyeq, Inc. — EyeQ nanoECP (510k cleared)

    Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoO&M Halyard, Inc. — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoExcite Medical of Tampa Bay, LLC — DRX9000C-SL Cervical Spinal Decompression System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoEsaote, S.p.A. — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoShanghai Saints Sages Surgical Co., Ltd. — SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) (510k cleared)

    Product code: LFL. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoWinner Medical Co., Ltd. — Procedure mask/Surgical mask/Face mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoGE Medical Systems SCS — CardIQ Suite (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoLin-Zhi International, Inc. — LZI Fentanyl III Enzyme Immunoassay (510k cleared)LIQTECH INTERNATIONAL INC

    Product code: DJG. Advisory committee: Clinical Toxicology. Type: Special

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k420d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 19, 2025device 510k419d agoEmpatica S.r.l. — EpiMonitor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 19, 2025device 510k419d agoBaisheng Medical Co., Ltd. — Electrosurgical Pads (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 19, 2025device 510k419d agoLeone S.P.A. — Leone Orthodontic Implant TAD (Temporary Anchorage Device) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device pma418d agoABBOTT MEDICAL — TactiFlex Ablation Catheter, Sensor Enabled (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoMedtronic, Inc. — CapSureFix Novus Lead (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoVentana Medical Systems, Inc. — PATHWAY® Anti-c-KIT (9.7) Primary Antibody (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoVentana Medical Systems, Inc. — VENTANA CLDN18 (43-14A) RxDx Assay (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoMainstay Medical Limited — ReActiv8 Implantable Neurostimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoZOLL Medical Corporation — AED Plus and Fully Automatic AED Plus (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoZoll Circulation, Inc. — TherOx Downstream Cartridge (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoCeramtec GmbH — 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 20, 2025device pma418d agoZOLL Medical Corporation — X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoSt Jude Medical — TactiCath Contact Force Ablation Catheter, Sensor Enabled (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoVentana Medical Systems, Inc. — VENTANA FOLR1 (FOLR-2.1) RxDx Assay (PMA supplement)MERIT MEDICAL SYSTEMS INC

    Supplement type: 30-Day Notice. Product code: QUL. Advisory committee: MG. Decision: OK30

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoAbiomed, Inc. — IMPELLA CP with Smart Assist (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoVentana Medical Systems, Inc. — PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoPhysio-Control, Inc. — LIFEPAK® CR2 Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoVentana Medical Systems, Inc. (Roche Tissue Diagnostics) — VENTANA MET (SP44) RxDx Assay (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoPhilips Medical Systems, Inc. — HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoVentana Medical Systems, Inc. — VENTANA ALK (D5F3) CDX ASSAY (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoPhysio-Control, Inc. — LIFEPAK 15 monitor/defibrillator; LIFEPAK 35 monitor/defibrillator; LIFEPAK 20e defibrillator/monitor; LIFEPAK 1000 defi (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoMedtronic, Inc. — 2292 Analyzer Cable (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
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    $MDT90.06+0.72%
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    $LIQT
    $MDT90.06+0.72%
    $MMSI91.54+1.99%
    $MMSI91.54+1.99%
    $MMSI91.54+1.99%
    $MMSI91.54+1.99%
    $MMSI91.54+1.99%
    $MMSI91.54+1.99%
    $MDT90.06+0.72%