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calendar

19,656 catalysts · 4,728 grant · 3,126 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 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: 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 filing3,126
  • 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 16, 2025

    50
    ›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 ↗
    ›Jun 20, 2025device pma418d agoPhysio-Control, Inc. — LIFEPAK 35 monitor/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 agoMedtronic, Inc. — Adapta, Versa, Sensia IPG (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoMedtronic Cardiac Rhythm Disease Management — CapSure Sense Lead (PMA supplement)

    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 — VENTANA MMR RxDx Panel (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 20, 2025device pma418d agoVentana Medical Systems, Inc. — VENTANA PD-L1 (SP263) ASSAY (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Jun 20, 2025device 510k418d agoShanghai Medconn Medical Technology Co., Ltd. — Medconn Glycated Hemoglobin Test system (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoSophysa — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoFlosonics Medical — FloPatch FP120 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoAsahi Intecc Co., Ltd. — Branchor X Balloon Guide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoAcera Surgical, Inc. — Restrata Soft Tissue Reinforcement (STR) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoThermo Fisher Scientific — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoBecton Dickinson — BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoPathpresenter Corporation — PathPresenter Clinical Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoPolynovo Biomaterials Pty, Ltd. — NovoSorb BTM (510k cleared)

    Product code: QSZ. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoErbe Elektromedizin GmbH — HybridAPC probe (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoClaronav — Navient Image Guided Navigation System (ENT) (955-NC-NC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoOvigenex, LLC — CollOvine™ Wound Dressing (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoHadleigh Health Technologies — Celsi Warmer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoEko.Ai Pte Ltd. D/B/A Us2.Ai — Us2.ca (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoYangzhou Fartley Medical Instrument Technology Co., Ltd. — Disposable Endoscopy Valve Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoMicroaire Surgical Instruments, LLC — PAL Sterilization Case (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoShenzhen Medke Technology Co., Ltd. — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoShenzhen Sunsred Technology Co.,Ltd — LED Facial Mask (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoSpident Co., Ltd. — EsCem RMGI (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoCanon Medical Systems Corporation — CT Scanner TSX-501R/1 V11.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k418d agoAsahi Intecc Co., Ltd. — FUBUKI XF-R Neurovascular Long Sheath (510k cleared)

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

    full page →fda device 510k ↗
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    $MMSI91.11+1.52%
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    $MMSI91.11+1.52%
    $MMSI91.11+1.52%
    $MMSI91.11+1.52%
    $BDX181.41+0.99%
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