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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 14, 2024

    50
    ›Oct 16, 2024device 510k665d agoDualams, Inc., Dba Airkor — UltraEzAir® (UEA1A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d 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 510k665d agoJLK, Inc. — JLK-CTP (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2024device 510k665d 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 510k665d 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 510k665d 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 510k665d 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 510k665d 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, 2024approval664d agoFENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

    Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Oct 17, 2024approval664d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: UBI. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Oct 17, 2024device 510k664d 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 510k664d agoAstura Medical — EGPS Navigated Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k664d 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 510k664d 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 510k664d 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 510k664d 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 510k664d agoHidroxa Medical AB — Hidroxa SE30 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k664d agoPerfuze, Ltd. — Zipline Access Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k664d agoGe Medical Systems, LLC — SIGNA MAGNUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2024device 510k664d 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 510k664d 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 510k664d 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, 2024approval663d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval663d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval663d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval663d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval663d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›Oct 18, 2024approval663d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

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

    full page →fda approvals ↗
    ›Oct 18, 2024approval663d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

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

    full page →fda approvals ↗
    ›Oct 18, 2024approval663d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

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

    full page →fda approvals ↗
    ›Oct 18, 2024approval663d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

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

    full page →relugolix →fda approvals ↗
    ›Oct 18, 2024device 510k663d 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 510k663d 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 510k663d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoDentscare Ltda — Vittra APS Unique Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 510k663d 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 ↗
    ›Oct 18, 2024device 510k663d agoBone Solutions, Inc. — Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (510k cleared)UL Solutions Inc.

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoEdelweiss Dentistry Products GmbH — edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoPhilips Medical Systems Nederland B.V. — dS Wrist coil 8ch 1.5T (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoBoston Scientific Corp — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoWellmed Dental Medical Supply Co., Ltd. — Dental Barrier and Sleeves (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 18, 2024device 510k663d agoWell-Life Healthcare Limited — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $LLY1223.99-0.64%
    $FRTRY
    $LLY1223.99-0.64%
    $LLY1223.99-0.64%
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    $LLY1223.99-0.64%
    $LLY1223.99-0.64%
    $MMSI91.54+1.99%
    $ALVO3.8000+0.80%
    $MMM
    $MTLS6.5600-1.06%
    $ACBM
    $BSX51.32+1.70%
    $ULS
    $ALVO3.8000+0.80%
    $ALVO3.8000+0.80%