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3,620 catalysts · 4,728 grant · 3,620 device 510k · 3,603 8k filing · 2,960 approval · 2,000 device pma · 2,000 device recall

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2026-08-31: 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: 1 catalyst2026-10-01: 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 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts2026-11-23: 0 catalysts2026-11-24: 0 catalysts2026-11-25: 0 catalysts2026-11-26: 0 catalysts2026-11-27: 0 catalysts2026-11-28: 0 catalysts2026-11-29: 0 catalysts
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type: device 510k×from 2025-03-03×clear all
type
  • grant4,728
  • device 510k3,620
  • 8k filing3,603
  • approval2,960
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall894
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Mar 3, 2025

    45
    ›Mar 3, 2025device 510k546d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — EnergyLounger (TY-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k546d agoDia Imaging Analysis, Ltd. — LVivo Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k546d agoJLK, Inc. — JLK-SDH (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k546d agoOlympus Medical Systems Corporation — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k546d agoBracco Diagnostics, Inc. — HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k546d agoVarian Medical Systems, Inc. — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Mar 3, 2025device 510k546d agoBeijing Nubway S&T Co., Ltd. — Q Switched Nd:YAG Laser machine (QNHF-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k545d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Disposable Cytology Brush (AF series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k545d agoLimacorporate — Biolox® Delta Revision heads (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k545d agoCeevra, Inc. — Ceevra Reveal 3+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k545d agoAlphatec Spine, Inc. — Calibrate Interbody Systems (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 4, 2025device 510k545d agoEuroteknika — iPhysio® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k544d agoVilex, LLC — TITANEX Screw Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k544d agoSiemens Healthcare GmbH — Prostate MR AI (VA10A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k544d agoPolynovo Biomaterials Pty, Ltd. — NovoSorb® MTX (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k544d agoMako Surgical Corp. — Mako Total Hip Application 5.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k544d agoAsahi Intecc Co., Ltd. — CROSSLEAD 0.018inch (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k544d agoBeckman Coulter, Inc. — Access Cortisol; DxC 500i Clinical Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2025device 510k544d agoWell Lead Medical Co., Ltd. — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoDia Imaging Analysis, Ltd. — LVivo Seamless (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoDermaroller GmbH — XCELLARISPRO TWIST microneedling device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoLaboratorios Biogalenic S.A. DE C.V. — Sterile Water USP and Sterile 0.9% Normal Saline USP (510k cleared)Revalesio Corp

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoCenterline Biomedical, Inc. — Intra-Operative Positioning System (IOPS®) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoXtreem Pulse, LLC — PureLift GLOW (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoZimmer, Inc. — Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoMedacta International S.A. — Versacem Acetabular Shell and Double Mobility HC Liners (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoBecton, Dickinson and Company — BD Phoenix™ Automated Microbiology System (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoMiach Orthopaedics, Inc. — BEAR® (Bridge-Enhanced ACL Restoration) Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k543d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSite Pathology Solution 5.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoEpiwatch, Inc. — EpiWatch Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoBatec Mobility, S.L. — Handbike Batec Electric (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoFort Defiance Industries, LLC — FRONT-LINE Field Sterilizer (FL135) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoShenzhen Rogin Medical Co., Ltd. — Apex Locator (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoIntradin (Shanghai) Machinery Co., Ltd. — Portable Wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoShanghai Longmann Tech Co., Ltd. — CuffTrek (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoGeistlich Pharma AG — Geistlich Bio-Flow® (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoDaeju Meditech Engineering Co., Ltd. — NOABLE LASER (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoAtmos Medizintechnik GmbH & Co. KG — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoCleerly, Inc. — Cleerly LABS (v2.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoEcential Robotics — Op.n(TM) Navigation (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoLelo, Inc. — Lelo Hex Lubricated Natural Rubber Latex Condom (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoMedartis AG — APTUS Hand System; APTUS Elbow Dorsal Olecranon (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) (510k cleared)

    Product code: FBN. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k542d agoOrthoPediatrics Corp. — Orthex External Fixation System (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗

    Week of Mar 10, 2025

    5
    ›Mar 10, 2025device 510k539d agoImplantcast GmbH — AGILON® XO Shoulder Replacement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k
    ← prev
    page 1 of 73
    next →
    539d ago
    Intuitive Surgical, Inc. — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k539d agoMedtronic Neurosurgery — Duet External Drainage and Monitoring System (EDMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k539d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k539d agoExactech, Inc. — Alteon® HA Femoral Stems (510k cleared)

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

    full page →fda device 510k ↗
    $KIDS
    $BDX189.52+0.74%
    $CODX1.51000.00%
    $MMSI90.49+1.06%
    $ISRG372.60+1.51%