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19,606 catalysts · 4,728 grant · 3,153 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 46 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 filing3,153
  • device 510k2,737
  • approval2,721
  • device recall2,000
  • device pma1,916
device adverse event
1,000
  • recall686
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 16, 2025

    30
    ›Jun 20, 2025device pma419d 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 510k419d 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 510k419d 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 510k419d 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 510k419d agoFlosonics Medical — FloPatch FP120 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d 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 510k419d 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 510k419d 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 510k419d 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 510k419d agoPathpresenter Corporation — PathPresenter Clinical Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d agoPolynovo Biomaterials Pty, Ltd. — NovoSorb BTM (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d 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 510k419d 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 510k419d agoOvigenex, LLC — CollOvine™ Wound Dressing (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d agoHadleigh Health Technologies — Celsi Warmer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d 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 510k419d 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 510k419d 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 510k419d 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 510k419d 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 510k419d agoSpident Co., Ltd. — EsCem RMGI (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d 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 510k419d 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 ↗
    ›Jun 20, 2025device 510k419d agoHcmed Innovations Co., Ltd. — AdheResp Smart Breath-actuated Mesh Nebulizer (510k cleared)GI Innovation Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d agoMedtronic, Inc. — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d agoAbbott Laboratories — Alinity i Rubella IgG (510k cleared)ABBOTT LABORATORIES

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d agoJinhua Qidian Vehicle Co., Ltd. — ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Thyroglobulin (Tg) (510k cleared)Dawn Sea Therapeutics

    Product code: MSW. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d agoWright Medical Technology, Inc. (Stryker) — Incompass Total Ankle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 20, 2025device 510k419d agoFoshan Guangyu Weilai Medical Equipment Co., Ltd. — LED LIGHT MASK (A093) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 23, 2025

    20
    ›Jun 23, 2025approval416d agoAMITRIPTYLINE HYDROCHLORIDE — FDA approvalAlgoTherapeutix SAS

    Sponsor: UNIQUE PHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 23, 2025approval
    ← prev
    page 7 of 393
    next →
    416d ago
    HADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →HADLIMA →fda approvals ↗
    ›Jun 23, 2025device pma416d agoAbiomed, Inc. — Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist (PMA supplement)Abion Inc

    Supplement type: Normal 180 Day Track. Product code: PYX. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 23, 2025device pma416d agoMicroVention, Inc. — Roadsaver/CASPER Carotid Stent Device (PMA supplement)MICROVISION, INC.

    Supplement type: Normal 180 Day Track No User Fee. Product code: NIM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 23, 2025device pma416d agoInspireMD, Ltd. — CGuard Prime Carotid Stent System (PMA)InspireMD, Inc.

    Product code: NIM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 23, 2025device pma416d agoUrotronic, Inc. — Optilume Urethral Drug Coated Balloon Catheter (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: QRH. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jun 23, 2025device pma416d agoAbiomed, Inc. — Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD (PMA supplement)Abion Inc

    Supplement type: Normal 180 Day Track. Product code: OZD. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 23, 2025device pma416d agoCooperVision, Inc. — comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jun 23, 2025device 510k416d agoRizhao Huge Biomaterials Company, Ltd. — TempFIT Temporary Crown and Bridge Resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k416d agoIdmed — WiTOF (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k416d agoApple, Inc. — Digital Prism Correction Feature (DPCF) (510k cleared)Apple Inc.

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k416d agoVipamat Sarl — Hippocampe Marathon and Trail (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k416d agoOpxion Technology, Inc. — OPXION Optical Skin Viewer (OPXSV1-01F) (510k cleared)WM TECHNOLOGY, INC.

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k416d agoOlympus Medical Systems Corp. — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k416d agoLiofilchem, Inc. — Ceftobiprole BPR 5 µg Disc (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k416d agoBrainlab AG — Cranial 4Pi Immobilization (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 23, 2025device 510k416d agoShenzhen AOJ Medical Technology Co., Ltd. — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 24, 2025approval415d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

    Sponsor: APOTEX INC. Form: TABLET. Route: ORAL

    full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗
    ›Jun 24, 2025approval415d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗
    ›Jun 24, 2025approval415d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    $MMSI91.11+1.52%
    $FRTRY
    $FRTRY
    $BDX181.41+0.99%
    $MDT90.02-0.73%
    $ABT109.72+1.01%
    $TMO447.81+1.31%
    $AAPL298.01+0.70%
    $MAPS0.4170+1.46%
    $NSPR0.7300+0.10%
    $MVIS4.4200+21.43%