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19,709 catalysts · 4,728 grant · 3,152 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: 0 catalysts2026-08-12: 45 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: 3 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 filing3,152
  • device 510k2,785
  • approval2,724
  • device recall2,000
  • device pma1,962
device adverse event
1,000
  • recall693
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 23, 2025

    27
    ›Jun 27, 2025device 510k412d agoPhilips Medical Systems Nederland B.V. — Philips iCT CT system (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoUstomed Instrumente Ulrich Storz GmbH & Co. KG — USTOMED Bone Fixation/Bone Augmentation Systems - PIN (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoBiomet 3i, LLC — T3 Pro Implants– ZimVie Packaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoMoon Surgical — Maestro System (REF100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoDigital Surgery Systems, Inc. (D.B.A True Digital Surgery) — Affirm 800 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoSorin Group Italia S.R.L. — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoBoston Scientific Corporation — VIKING™ Fixed Curve Diagnostic Catheter (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoMulti4 Medical AB — Multi4 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoNeuromodulatory Devices & Applications — Ampa One System (AMPA-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoSpine Wave, Inc. — Testa TP Pivoting Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoColoplast Corp. — Luja Coudé (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoGuangdong Yadeng Medical Apparatus Co., Ltd., — Integral Dental Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoScopio Labs , Ltd. — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (510k cleared)

    Product code: JOY. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoGenostis AF — Genostis Osteosynthesis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoCenterPoint Systems, LLC — CPS Locator 3D Plus Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoYian Medical Technology (Haining) Co., Ltd. — Dental CBCT X-ray System (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoEmpnia, Inc. — eMotus Respiratory Motion Management System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoRisu Medical Technology Co., Ltd. — Diode laser device (RF3120-BI) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoDent4you AG — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoRtm Vital Signs, LLC — RTMsense Respiratory Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoMicro-Tech (Nanjing) Co., Ltd. — Disposable Distal Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoPAJUNK GmbH Medizintechnologie — SonoPlex STIM; SonoPlex II (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoCork Medical — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoCathegenix (Xiamen) Co., Ltd. — LumenaTM Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoJeil Medical Corporation — FIX-C PEEK ACIF SA System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 29, 2025device 510k410d agoPendracare — Primum Hydrophilic Guiding Catheter (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 30, 2025

    23
    ›Jun 30, 2025device pma409d agoPhysio-Control, Inc. — LIFEPAK FLEX™ Lithium-ion Battery (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 30, 2025device pma
    ← prev
    page 12 of 395
    next →
    409d ago
    Baxter Healthcare Corp — FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (PMA supplement)Baxter Healthcare Corp

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

    full page →fda device pma ↗
    ›Jun 30, 2025device pma409d agoNevro Corporation — Nevro Corp Senza Spinal Cord Stimulation (SCS) System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 30, 2025device pma409d agoTherakos Development Limited — THERAKOS® CELLEX® Photopheresis System Procedural Kit (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 30, 2025device 510k409d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k409d agoCarlsmed, Inc. — aprevo® posterior/transforaminal lumbar interbody fusion device (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k409d agoFUJIFILM Healthcare Americas Corporation — Synapse PACS (7.5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k409d agoVoluntis — HeroTracker Sense (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k409d agoMycardium AI Limited — EchoConfidence (USA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k409d agoShenzhen Chuangtong Yigou Technology Co., Ltd. — Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k409d agoPiur Imaging GmbH — PIUR tUS inside (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k409d agoOtsuka America Pharmaceutical, Inc. — Otsuka Digital Feedback Device (510k cleared)Otsuka America Pharmaceutical Inc

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

    full page →fda device 510k ↗
    ›Jul 1, 2025approval408d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Jul 1, 2025approval408d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Jul 1, 2025device pma408d agoOrganox Limited — OrganOx metra System (PMA supplement)

    Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoSirtex Medical, Inc. — SIR-Spheres Y-90 resin microspheres (PMA supplement)

    Supplement type: Panel Track. Product code: NAW. Advisory committee: RA. Decision: APPR

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoCook Ireland, Ltd. — Zilver Flex(R) 35 Vascular Stent (PMA supplement)

    Supplement type: Panel Track. Product code: NIP. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoTransMedics, Inc. — Organ Care System™ (OCS™) Liver (PMA supplement)TransMedics Group, Inc.

    Supplement type: Real-Time Process. Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoBoston Scientific Corp — AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jul 1, 2025device pma408d agoABBOTT MEDICAL — HeartMate 3™ Left Ventricular Assist System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jul 1, 2025device 510k408d agoAbbott Molecular, Inc. — Alinity m CMV (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoHtl-Strefa S.A — droplet® personal lancets (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoAccess Vascular, Inc. — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (510k cleared)

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

    full page →fda device 510k ↗
    $MCLE
    $BSX51.19+1.45%
    $CARL
    $TMDX69.43-2.72%
    $TMO447.81+1.31%
    $BSX51.19+1.45%
    $BMY63.61-1.90%