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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 0 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 16 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Aug 11, 2025

    21
    ›Aug 14, 2025device 510k352d agoBiofire Diagnostics, LLC — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoGeistlich Pharma AG — Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoShenzhen Mlay Intelligent Technology Co., , Ltd. — IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoNeuroone Medical Technologies Corp. — OneRF Trigeminal Nerve Radiofrequency Probes (510k cleared)NEUROONE MEDICAL TECHNOLOGIES Corp

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoBrightonix Imaging — PHAROS (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoEos Imaging — VEA Align; spineEOS (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoiRhythm Technologies, Inc. — Zio® monitor (DFG0001) (510k cleared)TTM TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoBeckman Coulter, Inc. — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoSmart Alfa Teknoloji San. Ve Tic. A.S. — Nerveblox (510k cleared)KD Pharma Group SA

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoN & C Holdings, LLC — CP Relief Wand Rx - TENS/NMES (510k cleared)DCFC Holdings, LLC

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoHelios Biomedical, Inc. — Helios Dermal Scaffold (510k cleared)RNR BioMedical Inc

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoHeat IN A Click, LLC — FEATHER 01 02 03 04 (Model:01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoHealgen Scientific,, LLC — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) (510k cleared)NutriBand Inc.

    Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoAssure Tech., LLC — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (510k cleared)

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoJMS North America Corporation — JMS CAVEO A.V. Fistula Needle Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoFairtility , Ltd. — CHLOE BLAST (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoDunamis Medical, LLC — Dunamis Screw and Suture Locking System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoKLS Martin L.P. — KLS Martin Ixos System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoZimmer Biomet — Persona Partial Knee (510k cleared)ZIMMER BIOMET HOLDINGS, INC.

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

    full page →fda device 510k ↗
    ›Aug 15, 2025device 510k351d agoAtlas Spine, Inc. — Atlas Spine Project X Expandable Posterior Lumbar Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 16, 2025device 510k350d agoOsteoCentric Technologies — OsteoCentric® UnifiMI® TCS Plating System (510k cleared)

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

    full page →fda device 510k ↗

    Week of Aug 18, 2025

    29
    ›Aug 18, 2025device 510k348d agoMag & More GmbH — Apollo TMS Therapy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 18, 2025device 510k
    ← prev
    page 59 of 100
    next →
    348d ago
    Biotab, LLC — PnueAira (PNCU-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 18, 2025device 510k348d agoJJGC Indústria e Comércio de Materiais Dentários S.A. — Neodent Implant System - Zirconia Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 18, 2025device 510k348d agoO&M Halyard, Inc. — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

    Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated

    full page →fda device 510k ↗
    ›Aug 18, 2025device 510k348d agoGlobus Medical, Inc. — ANTHEM® Fracture System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Aug 18, 2025device 510k348d agoEvolution Spine — Evolution Spine Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 19, 2025device 510k347d agoOSSIO , Ltd. — OSSIOfiber® Interference Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 19, 2025device 510k347d agoRebotix — Remanufactured EndoWrist Tenaculum Forceps (420207) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 19, 2025device 510k347d agoHarps Europe Manufacturing GmbH — Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid (510k cleared)

    Product code: KGO. Advisory committee: General, Plastic Surgery. Type: Abbreviated

    full page →fda device 510k ↗
    ›Aug 19, 2025device 510k347d agoAgnes Medical Co., Ltd. — Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 19, 2025device 510k347d agoVenclose, Inc. — Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 19, 2025device 510k347d agoRebotix — Remanufactured EndoWrist Cadiere Forceps (420049) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 19, 2025device 510k347d agoRebotix — Remanufactured EndoWrist Long Tip Forceps (420048) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoBeckman Coulter, Inc. — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model W6) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoLiofilchem s.r.l. — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoTriMed, Inc. — Distal Xtremities System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoStryker GmbH — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (510k cleared)STRYKER CORP

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoZest Anchors, LLC — LOCATOR® Angled Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoSoftac Medical Technologies — EndoFix™Tissue Fixation System (510k cleared)Samson Medical Technologies LLC

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoWondfo USA Co, Ltd. — WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoMethinks Software, S.L — Methinks CTA Stroke (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoRebotix — Remanufactured EndoWrist Cobra Grasper (420190) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoArtrya Limited — Salix Coronary Plaque (V1.0.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoQuantalx Neuroscience, Ltd. — Delphi-MD System (510k cleared)

    Product code: SFN. Advisory committee: Neurology. Type: Direct

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoSiemens Medical Solutions USA, Inc. — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoComerge AG — T1D1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 20, 2025device 510k346d agoImplant Protesis Dental 2004, S.L. — IPD Dental Implant Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k345d agobioMerieux, Inc. — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (510k cleared)BIOMERICA INC

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

    full page →fda device 510k ↗
    $NMTC
    $DCFBS
    $TTMI
    $ZBH87.97+0.93%
    $NTRB2.9000-11.59%
    $SYK325.70-6.42%
    $BMRA
    $FRTRY
    $GMED79.93+1.27%