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19,683 catalysts · 4,728 grant · 3,153 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma

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  • grant4,728
  • 8k filing3,153
  • device 510k2,768
  • approval2,721
  • device recall2,000
  • device pma1,955
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

    50
    ›Jun 25, 2025device pma414d agoNeuros Medical, Inc. — Altius Direct Electrical Nerve Stimulation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoAllergan — Juvederm Injectable Gel (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoABBOTT MEDICAL — MitraClip™ G4 Clip Delivery System; MitraClip™ NTR Clip Delivery System; MitraClip™ XTR Clip Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoSyncardia Systems, LLC — Total Artificial Heart (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 25, 2025device pma414d agoABBOTT MEDICAL — TriClip™ G4 Delivery System; MitraClip™ G5 Delivery System, TriClip™ G5 Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 25, 2025device 510k414d agoCg Medtech Co., Ltd. — ANAX™ OCT Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoPrismatik Dentalcraft, Inc. — Flexible Partial Resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoS&G Biotech, Inc. — EGIS Biliary Double Bare Stent (BDB080405) (510k cleared)IO Biotech, Inc.

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoSysmex America, Inc. — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoSmith & Nephew, Inc. — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoExpanding Innovations, Inc. — X-PAC® LLIF Expandable Lateral Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoEnraf-Nonius, B.V. — Curapuls 670 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoStrait Access Technologies Holdings — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (510k cleared)SS&C Technologies Holdings Inc

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoBlue Belt Technologies, Inc. — CORIOGRAPH Pre-Op Planning and Modeling Services (510k cleared)BETA Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoPAJUNK GmbH Medizintechnologie — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoSysmex America, Inc. — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoGeniphys, Inc. — GeniPhys Collymer Self-Assembling Scaffold (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoFisher & Paykel Healthcare, Ltd. — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (510k cleared)

    Product code: BTT. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoKardium, Inc. — Globe® Pulsed Field System (510k cleared)Kardigan Inc

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

    full page →fda device 510k ↗
    ›Jun 25, 2025device 510k414d agoAnhui Jbh Medical Apparatus Co., Ltd. — Power Wheelchair (D26) (510k cleared)

    Product code: ITI. Advisory committee: Physical Medicine. Type: Special

    full page →fda device 510k ↗
    ›Jun 26, 2025approval413d agoPUR-WASH (PURIFIED WATER) — FDA approval

    Sponsor: NIAGARA PHARMS. Form: SOLUTION. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›Jun 26, 2025approval413d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

    Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

    full page →vandetanib →fda approvals ↗
    ›Jun 26, 2025device pma413d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d 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 26, 2025device pma413d agoMedtronic, Inc. — Freestyle Bioprosthesis, Models 995, 995CS, 995MS (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoBoston Scientific Corporation — Ranger™ Paclitaxel-Coated PTA Balloon Catheter (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic Vascular — Resolute Onyx (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic Vascular, Inc. — EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoBiosense Webster, Inc. — VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoVeryan Medical, Ltd. — BioMimics 3D Vascular Stent System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NIP. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Mosaic Bioprosthesis, Models 305, 310 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Hancock II Bioprosthesis, Models T505, T510 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoC.R. Bard, Inc. — Covera™ Vascular Covered Stents (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

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

    full page →fda device pma ↗
    ›Jun 26, 2025device 510k413d agoVerity Medical , Ltd. — NeuroTrac® MyoPlus Pro (MYO120U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoMaxx Orthopedics, Inc. — Freedom® Total Knee System – Titanium Tibial Base Plate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoInMode , Ltd. — Optimas MAX System (510k cleared)InMode Ltd.

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoSonic Incytes Medical Corp — Velacur One (LI-1100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoShenzhen Bestman Instrument Co., Ltd. — Doppler FHR Detector (BF-500D+, BF-560) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoJoytech Healthcare Co. , Ltd. — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoNeuralytix, LLC — Neuralytix iD3 System (NTX-9001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoPathAI, Inc. — AISight Dx (510k cleared)Pathos AI Inc

    Product code: QKQ. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoYichang Xinxin Paper Products Co., Ltd. — Sterilization Pouch and Roll (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoHardy Diagnostics — HardyDisk AST Gepotidacin 10µg (GEP10) (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $SNN30.01-0.23%
    $BSX51.19+1.45%
    $MDT90.02-0.73%
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    $BETA16.10+2.09%
    $SSNC
    $EW91.33-2.47%
    $MDT90.02-0.73%
    $MDT90.02-0.73%
    $MDT90.02-0.73%
    $MDT90.02-0.73%
    $MDT90.02-0.73%
    $EW91.33-2.47%
    $INMD