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23,077 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,126 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 97 catalysts2026-08-12: 19 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: 2 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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  • device 510k4,900
  • grant4,728
  • approval3,532
  • 8k filing3,126
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 7, 2024

    29
    ›Oct 11, 2024approval670d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

    Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 11, 2024approval670d agoHYMPAVZI (MARSTACIMAB-HNCQ) — FDA approvalmarstacimab

    Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →marstacimab →fda approvals ↗
    ›Oct 11, 2024approval670d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalANI PHARMACEUTICALS INC

    Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 11, 2024device 510k670d agoBeckman Coulter, Inc. — Access Toxo IgM II (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoOrmco Corporation — Spark™ Clear Aligner System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoAiros Medical, Inc. — ARTAIRA Arterial Compression Device (AACD01) (510k cleared)AVANOS MEDICAL, INC.

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoQx World, Ltd. — QUEX ED; QUEX S (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoAnhui Deepblue Medical Technology Co., Ltd. — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoProgressive Aligners, Inc. — Progressive Orthodontics App (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoAccure Acne, Inc. — Accure Laser System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoSterilmed, Inc. — Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoDongguan Tutamen Metalwork Co., Ltd. — PBM Hair Therapy Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoJdentalcare Srl — JDZygoma dental implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoCopan Italia Spa — UriSponge™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoFujifilm Corporation — Hood (DH-083ST) (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoHeidelberg Engineering GmbH — SPECTRALIS with Flex Module (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoSiemens Medical Solutions USA, Inc. — syngo Application Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoDongguan Boyuan Intelligent Technology Co.,Ltd — LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoPermantis Public Health — PPH Saliva Collection Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoSTERIS Corporation — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoOrtho Development Corp. — Legend® Acetabular Shell (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoBelun Technology Company Limited — Belun Ring BLR-200 (BLR-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoCmr Surgical Limited — Versius Surgical System (510k cleared)

    Product code: SCV. Advisory committee: General, Plastic Surgery. Type: Direct

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoSamsung Medison Co., Ltd. — HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoPeters Surgical — Monotime and Optime R (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoZhejiang Innuovo Rehabilitation Devices Co.,Ltd — Mobility Scooter (N3473) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoQpix Solutions, Inc. — X Sensor (Model: IOS-A15IF, HDI-15DGF) (510k cleared)UL Solutions Inc.

    Product code: MUH. Advisory committee: Dental. Type: Special

    full page →fda device 510k ↗
    ›Oct 11, 2024device 510k670d agoCenterline Biomedical, Inc. — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 12, 2024device 510k669d agoNb Medical Company Limited — NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 14, 2024

    21
    ›Oct 15, 2024approval666d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

    Sponsor: IPCA LABS LTD. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 15, 2024approval
    ← prev
    page 2 of 462
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    666d ago
    OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 15, 2024approval666d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 15, 2024device 510k666d agoCircle Cardiovascular Imaging, Inc. — cvi42 Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k666d agoScivita Medical Technology Co., Ltd. — Single-use Extraction Baskets (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k666d agoDen-Mat Holdings, LLC — DenMat Bulk Fill Composite (510k cleared)DCFC Holdings, LLC

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k666d agoShenzhen Piocreat 3D Technology Co., Ltd. — Denture Base Resin (PN-Denture (Red, White)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k666d agoInari Medical, Inc. — Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k666d agoTautona Group — TauTona Pneumoperitoneum Assist Device (TPAD) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k666d agoMediimg Corporation — VINT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k666d agoCure Point Therapeutics, Inc. — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) (510k cleared)Checkpoint Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Oct 15, 2024device 510k666d agoSteritec Products Mfg. (A Getinge Group Company) — Getinge Assured MI Steam Migrating Integrator (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024approval665d agoVYALEV (FOSCARBIDOPA) — FDA approval(foscarbidopa + foslevodopa)

    Sponsor: ABBVIE. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →(foscarbidopa + foslevodopa) →fda approvals ↗
    ›Oct 16, 2024device 510k665d agoStryker Instruments — Stryker Steri-Shield 8 Surgical Hoods and Togas (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d agoAugmedics, Ltd. — xvision Spine System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d agoAbbott Laboratories Diagnostics Division — Alkaline Phosphatase (510k cleared)ABBOTT LABORATORIES

    Product code: CJE. Advisory committee: Clinical Chemistry. Type: Special

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d agoCerenovus, Inc. — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d agoLi Medical Corporation , Ltd. — RELIEEV Uterine Manipulator Injector (CUMI 5.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d agoCerenovus, Inc. — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d agoShenzhen Safesecure Medical Infection Control Tech Co. , Ltd. — Safe Secure Sterilization Pouches and Rolls (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d agoPeytant Solutions, Inc. — AMStent® Tracheobronchial Covered Stent System (510k cleared)PDF SOLUTIONS INC

    Product code: SDB. Advisory committee: Anesthesiology. Type: Direct

    full page →fda device 510k ↗
    $STE239.63+0.30%
    $ANIP74.71-1.39%
    $ULS
    $DFUKF
    $AVNS
    $PFE26.63-1.57%
    $ABBV249.50+0.61%
    $PDFS
    $ABT109.72+1.01%
    $MOBI
    $DCFBS