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2,652 catalysts · 4,728 grant · 3,603 8k filing · 2,706 approval · 2,652 device 510k · 2,000 device recall · 1,878 device pma

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type: device 510k×from 2025-06-16×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,706
  • device 510k2,652
  • device recall2,000
  • device pma1,878
device adverse event
1,000
  • recall681
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 16, 2025

    50
    ›Jun 16, 2025device 510k441d agoExpanding Innovations, Inc. — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoSiemens Healthcare GmbH — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoBeckman Coulter, Inc. — Access hsTnI (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoGuangdong Ecan Medical Co., Ltd. — Silicone Urethral Catheter (Silicone Urethral Catheter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoNavier Medical — Mosaic (V1.0.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoSiemens Shenzhen Magnetic Resonance , Ltd. — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoGeomedi Co,., Ltd. — Geo Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoMethinks Software, S.L — Methinks NCCT Stroke (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoEvoEndo, Inc. — EvoEndo Single-Use Endoscopy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k441d agoBecton, Dickinson and Company — BD Veritor System for SARS-CoV-2 (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoFziomed, Inc. — Oxiplex® (510k cleared)

    Product code: QVL. Advisory committee: Orthopedic. Type: Direct

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoNano-Ditech Corporation — Nano-Check Influenza+COVID-19 Dual Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoKl-Kepong Rubber Products Sdn. Bhd. — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoVitalSigns Technology Co., Ltd. — VitalSigns 1-Lead Holter (VSH101) (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoAnika Therapeutics, Inc. — Integrity™ Implant (510k cleared)Anika Therapeutics, Inc.

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoBridge TO Life — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (510k cleared)Revalesio Corp

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoBard Peripheral Vascular, Inc. — Dorado™ PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoShanghai United Imaging Healthcare Co., Ltd. — uOmniscan (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoBrainlab AG — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoKonica Minolta, Inc. — SKR 3000 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoTissium SA — COAPTIUM Connect with TISSIUM LIGHT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k440d agoWuxi Hisky Medical Technologies Co., Ltd. — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoShenzhen Wikkon Precision Technologies Co., Ltd. — Extracorporeal Shock Wave Lithotripter (U200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Ureteral Stents (AF-D series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoSeaSpine Orthopedics Corporation — Virata Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoAcumed, LLC — The Acumed Wrist Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoHappy Health, Inc. — Happy Health Home Sleep Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoCenterPoint Systems, LLC — FlexiGo 3D Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoFisher & Paykel Healthcare Limited — F&P Nova Nasal Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoCuriteva, Inc. — Curiteva Porous PEEK Standalone ALIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoBard Access Systems, Inc. — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoConmed Corporation — CONMED Argo Knotless® Anchor (510k cleared)CONMED Corp

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoHMC Premedical S.p.A. — Enteral Drainage System, Enteral Medicine straw (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoBioline Dental Implant Systems, Ltd. — Bioline Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoJiangxi Jiangte Electric Vehicle Co., Ltd. — Mobility Scooter (JT10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoEyeq, Inc. — EyeQ nanoECP (510k cleared)

    Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoO&M Halyard, Inc. — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoExcite Medical of Tampa Bay, LLC — DRX9000C-SL Cervical Spinal Decompression System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoEsaote, S.p.A. — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoShanghai Saints Sages Surgical Co., Ltd. — SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoWinner Medical Co., Ltd. — Procedure mask/Surgical mask/Face mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoGE Medical Systems SCS — CardIQ Suite (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoLin-Zhi International, Inc. — LZI Fentanyl III Enzyme Immunoassay (510k cleared)LIQTECH INTERNATIONAL INC

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

    full page →fda device 510k ↗
    ›Jun 18, 2025device 510k439d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 19, 2025device 510k438d agoEmpatica S.r.l. — EpiMonitor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 19, 2025device 510k438d 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 510k438d 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 510k437d 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 ↗
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