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12,031 catalysts · 3,350 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma

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  • 8k filing3,350
  • grant2,283
  • approval1,778
  • device 510k1,169
  • device adverse event1,000
  • device pma849
  • device recall655
  • earnings584
  • recall282
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 15, 2025

    50
    ›Dec 19, 2025device 510k241d agoMikron Makina Sanayi VE Tic. Ltd. Sti. — MSFX MIKRON PEEK CAGES (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoLeadoptik, Inc. — LIA-1 Catheter (542-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoDiazyme Laboratories, Inc. — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (510k cleared)Dolby Laboratories, Inc.

    Product code: DFH. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoRhythm AI, Ltd. — STAR Apollo™ Mapping System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoQingdao Bright Moon Biomedical Materials Co., Ltd. — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoWontech Co., Ltd. — SANDRO Dual (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoTruvian Health — Tru Liver Health Test Panel (510k cleared)

    Product code: CJE. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoTOPIA MEDTECH LIMITED — Alzevita (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoSouthern Medical (Pty) , Ltd. — Southern Craniomaxillofacial (CMF) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoKulzer, LLC — iCEM Universal Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoSunglor Technology Co., Ltd. — LED Light Therapy Device (Models: SG-FM, SG-FE) (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoCsd Labs — eMurmur Heart AI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoFisher & Paykel Healthcare, Ltd. — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoUnipack, LLC — Chiavaye Personal Moisturizer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoOrtho Development Corp. — Balanced Knee System TriMax Porous Femoral Components (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoEncore Medical L.P. — EMPOWR Knee (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoLeadoptik, Inc. — LIA Console (542-7) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoMerit Medical Systems, Inc. — SCOUT MD Surgical Guidance System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoRadformation, Inc. — ClearCalc Model RADCA V2.6 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitor (CL1902A, CL2103F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoGuangdong Youmeng Electrical Technology Co., Ltd. — Wearable Electric Breast Pump (YM-8803) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoPoskom Co., Ltd. — Airbile-100 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoShenzhen Xinlong Precision Plastic Mold Products Co., Ltd. — LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoNucletron B.V. — Rectal Applicator (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoGuangdong Youmeng Electrical Technology Co., Ltd. — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoSiemens Healthcare GmbH — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoPari Respiratory Equipment, Inc. — eRapid with eTrack System (510k cleared)PARI Respiratory Equipment Inc

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoMedicrea International S.A.S. (Medtronic) — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoNingbo Ranor Medical Science & Technology Co., Ltd. — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoSanhe Lefis Electronics Co., Ltd. — CO2 Laser Therapy System (Model: LFS-D9U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k241d agoShenzhen Ykd Technology Co., Ltd. — Spo2 Sensor CSS032D (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device pma241d agoMedtronic Vascular — Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoAbiomed, Inc. — Impella CP with SmartAssist; Impella 5.5 with SmartAssist (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoSeikagaku Corp. — SUPARTZ FX; VISCO-3 (PMA supplement)Seikagaku Corp

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoIrvine Biomedical, Inc. — Cool Point™ Tubing Set (PMA supplement)RNR BioMedical Inc

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoBerlin Heart, Inc. — EXCOR Pediatric Ventricular Assist Device (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoSymatese — Evolysse Injectable Hyaluronic Acid (PMA supplement)

    Supplement type: Real-Time Process. Product code: LMH. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoEndotronix, Inc. — CorPASS System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoMedtronic Neuromodulation — Medtronic Altaviva System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoGraphic Controls D.B.A. Vermed — HeartSync Multifunction Disposable Single-Use Defibrillator Pads (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoABBOTT MEDICAL — Volt™ PFA System (PMA)

    Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoGuidant Corp. — VALITUDE™ (Model U125) VALITUDE™ X4 (Model U128) VISIONIST™ (Models U225, U226) VISIONIST™ X4 (Model U228) Firmware Vers (PMA supplement)Guident Corp.

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® FORTEGRA Venous Stent (PMA)

    Product code: QTL. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoBoston Scientific Corp — ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoDiaSorin, Inc. — LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MYL. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoW. L. Gore & Associates, Inc. — GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4 (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoBoston Scientific — ESSENTIO™ MRI (Models L110, L111, L131) PROPONENT™ MRI (Models L210, L211, L231) ACCOLADE™ MRI (Models L310, L311, L331) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Dec 19, 2025device pma241d agoDiaSorin, Inc. — LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
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    $EMI
    $DLB
    $DFUKF
    $VIOT
    $GDNT
    $FRTRY
    $BSX51.83+0.27%
    $MMSI90.76+0.29%
    $BSX51.83+0.27%