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23,587 catalysts · 5,000 device 510k · 4,728 grant · 3,888 approval · 3,180 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 73 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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  • device 510k5,000
  • grant4,728
  • approval3,888
  • 8k filing3,180
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 14, 2024

    50
    ›Oct 16, 2024device 510k666d 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 510k666d 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 510k666d 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 510k666d 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 510k666d 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 510k666d 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 ↗
    ›Oct 16, 2024device 510k666d agoDualams, Inc., Dba Airkor — UltraEzAir® (UEA1A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k666d agoShenzhen Hbcare Technology Co.,Ltd — Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k666d agoJLK, Inc. — JLK-CTP (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k666d agoVy Spine, LLC — Vy Spine™ VyLam™ Laminoplasty System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k666d agoEdwards Lifesciences — Cerebral Autoregulation Index (CAI) Algorithm (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k666d agoVarian Medical Systems, Inc. — ONCOZENE Microspheres (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k666d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k666d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically powered wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024approval665d agoFENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

    Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Oct 17, 2024approval665d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: UBI. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Oct 17, 2024device 510k665d agoHager& Meisinger GmbH — MP Pin flat without thread (36BMP000020/MP20) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoAstura Medical — EGPS Navigated Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoEpitel, Inc. — REMI-AI Rapid Detection Module (REMI-AI RDM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoBaui Biotech Co., Ltd. — NOVA Minimally Invasive System (510k cleared)Oneness Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoMedical Graphics Corporation — Ascent Cardiorespiratory Diagnostic Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically powered wheelchair (HP202) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoHidroxa Medical AB — Hidroxa SE30 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoPerfuze, Ltd. — Zipline Access Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoGe Medical Systems, LLC — SIGNA MAGNUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoShenzhen Huaruibo Electric Appliances Co., Ltd. — IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoImbed Biosciences — Microlyte Ag/Lidocaine (510k cleared)Sustained Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k665d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (F5055) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval664d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

    Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 18, 2024approval664d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

    Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 18, 2024approval664d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

    Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 18, 2024approval664d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

    Sponsor: SUMITOMO PHARMA AM. Form: TABLET. Route: ORAL

    full page →relugolix →fda approvals ↗
    ›Oct 18, 2024device 510k664d agoStimlabs, LLC — Corplex P/ Theracor P/ Allacor P (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoPhilips Medical Systems Nederland B.V. — dS Knee Coil 8ch 1.5T (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoDentscare Ltda — Vittra APS Unique Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoOrthosoft Inc. (d/b/a) Zimmer CAS — ROSA® Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda — FREDDO (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoEclectic Co., Ltd. — PreXolid CAD/CAM abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT 7500 RT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d ago3M Company — 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (510k cleared)3M CO

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoMaterialise NV — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoSleepnet Corporation — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoAcro Biomedical Co., Ltd. — ABCcolla® Collagen ADM Scaffold (510k cleared)ACRO BIOMEDICAL CO., LTD.

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k664d agoSafepath Medical, Inc. — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
    page 12 of 472
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    $ABT111.16+1.31%
    $FRTRY
    $EW91.33-2.47%
    $PDFS
    $LLY1214.72-0.02%
    $LLY1214.72-0.02%
    $MMSI90.59-0.57%
    $ALVO3.8050+0.13%
    $LLY1214.72-0.02%
    $ALVO3.8050+0.13%
    $LLY1214.72-0.02%
    $MTLS6.5600-1.06%
    $ALVO3.8050+0.13%
    $ACBM
    $MMM
    $LLY1214.72-0.02%