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23,423 catalysts · 5,000 device 510k · 4,728 grant · 3,778 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 510k5,000
  • grant4,728
  • approval3,778
  • 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 Sep 23, 2024

    6
    ›Sep 27, 2024device 510k684d agoBalt USA, LLC — Optima Coil System (OptiBlock Line Extension) (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — HIGHERDOSE Red and Infrared Light Mask (MK66-L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoJLK, Inc. — JBS-LVO (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Temperature Module (TM0002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoInari Medical, Inc. — ClotTriever XL Catheter (41-102) (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoMedline Industries, LP — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (510k cleared)

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

    full page →fda device 510k ↗

    Week of Sep 30, 2024

    44
    ›Sep 30, 2024approval681d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

    Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

    full page →trofinetide →fda approvals ↗
    ›Sep 30, 2024approval
    ← prev
    page 6 of 469
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    681d ago
    DAYBUE (TROFINETIDE) — FDA approvaltrofinetide

    Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

    full page →trofinetide →fda approvals ↗
    ›Sep 30, 2024device 510k681d agoKem Medical Products Corporation — Kem Medical Lead-free Chemical Indicators for Steam Sterilization (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoDentalmax Co., Ltd. — LUXEN 5G (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoMikron Makina Sanayi VE Ticaret Ltd. Sti. — MSFX MIKRON SPINAL FIXATION SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoRecensmedical, Inc. — OcuCool (510k cleared)

    Product code: QZQ. Advisory committee: Unknown. Type: Direct

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoYsi, Inc. — YSI 2900C Biochemistry Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoGuangzhou Wondfo Biotech Co., Ltd. — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoMicroPort NeuroTech (Shanghai) Co., Ltd. — Numen™ Coil Embolization System; NumenFR™ Detachment System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoProcept Biorobotics — AQUABEAM Robotic System (AB2000) (510k cleared)PROCEPT BioRobotics Corp

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoVantis Vascular, Inc. — CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024approval680d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Oct 1, 2024approval680d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Oct 1, 2024device 510k680d agoWallaby Medical — Esperance 3+ Aspiration Catheter System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoSpringbok, Inc. — MuscleView (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoBodyvision Medical , Ltd. — LungVision (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoYongkang Youha Electric Appliance Co., Ltd. — Electric wheelchair (YHWL002, YHWL003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoGe Hualun Medical Systems Co. , Ltd. — Definium Pace Select ET (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoSamsung Electronics Co., Ltd. — GM85 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Disposable Endoscope Valves Set (AF series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoAicheck Biotech, Inc. — Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC (510k cleared)

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoThermo Fisher Scientific — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoSprintray, Inc. — Crown HT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024approval679d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Oct 2, 2024device 510k679d agoLiaoning Upcera Co., Ltd. — Ceramic Etchant (HF-5 and HF-9) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Versana Premier; Versana Premier Lotus; LOGIQ F (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoTherapixel — MammoScreen BD (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoLuminex Molecular Diagnostics, Inc. — NxTAG® Respiratory Pathogen Panel (510k cleared)Insight Molecular Diagnostics Inc.

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoArthrex, Inc. — Arthrex Virtual Implant Positioning (VIP) System Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoMomentis Surgical , Ltd. — Anovo Surgical System (model 6N) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoFoundation Surgical Group, Inc. — Interwedge® Standalone Lateral (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoRoute 92 Medical, Inc. — 8F Modified Sheath System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoArtfx Medical — ARTFX Lumbar PEEK Cages (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoCollagen Matrix, Inc. — RejuvaKnee™ Collagen Meniscus Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoOsteoremedies, LLC — REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k679d agoPerspectum, Ltd. — VitruvianScan (v1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 3, 2024approval678d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Oct 3, 2024approval678d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

    Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 3, 2024approval678d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

    Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL

    full page →hydrocodone bitartrate ER →fda approvals ↗
    ›Oct 3, 2024approval678d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 3, 2024approval678d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 3, 2024approval678d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

    Sponsor: RISING. Form: SPRAY, METERED. Route: NASAL

    full page →BUTORPHANOL TARTRATE →fda approvals ↗
    ›Oct 3, 2024approval678d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Oct 3, 2024device 510k678d agoHangzhou Thales Medtech Co., Ltd. — Additive Manufacturing Zirconia Customized Restoration (510k cleared)

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

    full page →fda device 510k ↗
    $MOBI
    $ACAD29.38-0.03%
    $ACAD29.38-0.03%
    $PRCT
    $NVS155.21-1.01%
    $TMO447.81+1.31%
    $ANIP74.71-1.39%
    $NVS155.21-1.01%
    $IMDX
    $BMY63.75-1.68%