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5,000 catalysts · 18,987 approval · 5,159 phase readout · 5,000 device 510k · 4,728 grant · 2,516 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 60 catalysts2026-07-30: 13 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 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: 0 catalysts2026-08-14: 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: 0 catalysts2026-10-22: 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 readout5,159
  • device 510k5,000
  • grant4,728
  • 8k filing2,516
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa319
  • therapy area

    no tagged catalysts yet

    Week of Jun 2, 2025

    38
    ›Jun 5, 2025device 510k420d agoGrumpy Innovation, Inc. — Portare System (FA-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoEstetic Ceram AG — zirkon; structure; LFU shades, stains and glazes (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoCorin U.S.A. Limited — Trinity EVO Acetabular Shell (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoNihon Kohden Digital Health Solutions, LLC — Central Station (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoIcu Medical, Inc. — Clave™ Neutral-Displacement Needlefree Connectors (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoOlympus Medical Systems Corp. — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoShenzhen Idea Light Limited — Red Light Hair Growth Cap (LP-RJVGRW-BLK) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoDeepHealth, Inc. — TechLive (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoGe Medical Systems, LLC — Sonic DL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoSynapse Biomedical, Inc. — Synchrony (20-3000) (510k cleared)RNR BioMedical Inc

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoMedtronic Navigation, Inc. — Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k420d agoBrightheart — BrightHeart View Classifier (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoGlobus Medical, Inc. — ONVOY™ Acetabular System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoHebei JT Medical Co., Ltd. — Nd: YAG Laser Therapy System (QN-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoGeister Medizin Technik GmbH — Geister K-Rex rongeurs (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoSpine Wave, Inc. — Annex® 2 Adjacent Level System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoCreo Medical, Ltd. — SpydrBlade Flex Instrument (PRD-RG1-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoSora Neuroscience, Inc. — Cirrus Resting State fMRI Software (510k cleared)Alto Neuroscience, Inc.

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoQuanta System Spa — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoEmpatica S.r.l. — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoSi-Technology, LLC — SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (510k cleared)Singh Biotechnology LLC

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoOmnia Medical, LLC — Omnia Medical PsiF DNA™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoTybr Health — TYBR Collagen Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoNingbo Ican Machines Co., Ltd. — Steam Sterilizer (2545D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoConvatec Limited — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoMBA Biotech Co., Ltd. — MBA Biotech Implant System (510k cleared)Oneness Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoMah Sing Healthcare Sdn. Bhd. — Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoCnS Medical Co., Ltd. — DELPHI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoLuminex Corporation — LIAISON PLEX Gram-Positive Blood Culture Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoSteris — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoGeorge Courey, Inc. — GCI Sterilization Wrappers (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoMediclus Co., Ltd. — Once-Fil Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoMomentis Surgical , Ltd. — Anovo Surgical System (6Ne) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoGuangzhou Ahead Intelligent Technology Co., Ltd. — Light Therapy System (M500, L6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoKarl Storz SE & CO. KG — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k419d agoShenzhen Desida Technology Co., Ltd. — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jun 7, 2025device 510k418d agoLevita Magnetics International Corp — Magnetic Surgical System (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 9, 2025

    12
    ›Jun 9, 2025device 510k416d agoOneness Biotech Co., Ltd. — Bonvadis® (510k cleared)Oneness Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 9, 2025device 510k
    ← prev
    page 46 of 100
    next →
    416d ago
    Nanjing Bestview Laser S&T Co., Ltd. — CO2 Laser Machine (Lume) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 9, 2025device 510k416d agoBiocorp Production — MallyaG Injection Pen Adapter (MallyaG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 9, 2025device 510k416d agoShenzhen Sungrow Led Technology Co., Ltd. — LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k415d agoDRTECH Corporation — EXTRON 3; EXTRON 5; EXTRON 7 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k415d agoFujifilm Corporation — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k415d agoEndymed Medical, Ltd. — EndyMed PRO MAX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k415d agoNihon Kohden Corporation — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (510k cleared)Nihon Kohden Corporation/ADR

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k415d agoRoche Diagnostics — Elecsys Anti-SARS-CoV-2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k415d agoViz. Ai, Inc. — Viz Subdural+, Viz SUBDURAL PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k415d agoFomed Industries, Inc. — Dental Barrier and Sleeves (510k cleared)Biomed Industries Inc

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k415d agoVitaltec Corporation — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (510k cleared)

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

    full page →fda device 510k ↗
    $STE234.83+1.95%
    $FRTRY
    $ANRO
    $GMED79.93+1.27%
    $ICUI166.53+0.46%
    $NHNKF