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20,120 catalysts · 4,728 grant · 3,126 8k filing · 3,076 device 510k · 2,774 approval · 2,000 device pma · 2,000 device recall

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  • grant4,728
  • 8k filing3,126
  • device 510k3,076
  • approval2,774
  • device pma2,000
  • device recall2,000
  • device adverse event1,000
  • recall751
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 26, 2025

    50
    ›May 28, 2025device 510k441d agoTermosalud S.L. — Zionic Pro Max (Radiofrequency) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoBoston Scientific Corporation — OptiMap™ System (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoTaiwan Medical Imaging Co., Ltd. — TAIMedImg DeepMets (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoSurGenTec, LLC — OsteoFlo HydroFiber (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoOpcom Medical, Inc. — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoIradimed Corporation — MRidium 3870 MRI Infusion Pump System (3870) (510k cleared)IRADIMED CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoIschemaview, Inc. — Rapid MLS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoSmart Soft Healthcare AD — CoLumboX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025approval440d agoFOCINVEZ (FOSAPREPITANT DIMEGLUMINE) — FDA approvalAthenex Inc (Inactive)

    Sponsor: STERISCIENCE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›May 29, 2025approval440d agoMETHOTREXATE — FDA approvalMaxtrex

    Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →Maxtrex →fda approvals ↗
    ›May 29, 2025device pma440d agoPremia Spine, Ltd. — TOPS™ System (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoNuvasive, Inc. — Simplify® Cervical Artificial Disc (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)DFB Soria LLC

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Scoreflex NC Scoring PTCA Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoJohnson & Johnson Surgical Vision, Inc. — Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System (PMA supplement)JOHNSON & JOHNSON

    Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoBoston Scientific Corp — VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Special (Immediate Track). Product code: NHL. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›May 29, 2025device 510k440d agoShenzhen Astec Technology Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoBaylis Medical Company, Inc. — VersaCross Connect™ Transseptal Dilator (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoReflow Medical, Inc. — Spur Peripheral Retrievable Stent System (510k cleared)

    Product code: SEU. Advisory committee: Cardiovascular. Type: Direct

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoMedtronic Navigation — Visualase V2 MRI-guided Laser Ablation System (9736422) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoOsteonic Co., Ltd. — SIGNEX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoTerumo Europe N.V. — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoShanghai AnQing Medical Instrument Co., Ltd. — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoYueying Medical Instruments (Langfang) Co., Ltd. — Dental Barrier and Sleeves (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoPiccolo Medical, Inc. — PM2+ System and SmartPICC Stylet (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Voluson™ Performance 16; Voluson™ Performance 18 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoCochlear — Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoEpic Medical Pte. , Ltd. — ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoNeurent Medical , Ltd. — NEUROMARK System (NMK00301) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoKuraray Noritake Dental, Inc. — CERABIEN MiLai (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoMasimo Corporation — Radius VSM and Accessories (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoRemex Medical Corp. — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoGerium Medical, Ltd. — BiliWrap (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoArthrex, Inc. — SuturePatch Tissue Reinforcement (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025approval439d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

    Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

    full page →ACETAZOLAMIDE →fda approvals ↗
    ›May 30, 2025device pma439d agoMedtronic, Inc. — Epsila EV Extravascular Lead (EV2401) (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoInspire Medical Systems — INSPIRE II UPPER AIRWAY STIMULATOR (PMA supplement)Inspire Medical Systems, Inc.

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoMedtronic, Inc. — Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoZoll Manufacturing Corporation — WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoMedtronic, Inc. — Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Scoreflex NC Scoring PTCA Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoBausch & Lomb, Inc. — enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (PMA supplement)Bausch & Lomb Corp

    Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoCook, Inc. — Zenith® Iliac Branch (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoBausch & Lomb, Inc. — enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (PMA supplement)Bausch & Lomb Corp

    Supplement type: 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoZoll Manufacturing Corporation — WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (PMA supplement)

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

    full page →fda device pma ↗
    ›May 30, 2025device pma439d agoZOLL Medical Corporation — AED 3 Semi-Automatic, AED 3 Fully Automatic (PMA supplement)

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

    full page →fda device pma ↗
    ← prev
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    $FRTRY
    $PMI0.1821-4.66%
    $MASI
    $MDT90.68+1.42%
    $IRMD
    $JNJ259.80-0.77%
    $BSX51.19+1.45%
    $MCLE
    $BSX51.19+1.45%
    $MDT90.68+1.42%
    $INSP42.44+0.38%
    $MDT90.68+1.42%
    $MDT90.68+1.42%
    $BLCO16.87+0.24%
    $MDT90.68+1.42%
    $BLCO16.87+0.24%