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23,207 catalysts · 4,956 device 510k · 4,728 grant · 3,543 approval · 3,189 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: 0 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 510k4,956
  • grant4,728
  • approval3,543
  • 8k filing3,189
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Nov 18, 2024

    25
    ›Nov 21, 2024device 510k630d agoCepheid® — Xpert vanA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoDepuy Ireland UC — ATTUNE™ Revision Hinge Knee (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k630d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Ankle Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024approval629d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

    Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

    full page →teclistamab →fda approvals ↗
    ›Nov 22, 2024approval629d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

    Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Nov 22, 2024approval629d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

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

    full page →fda approvals ↗
    ›Nov 22, 2024approval629d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

    Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →mosunetuzumab →fda approvals ↗
    ›Nov 22, 2024approval629d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 22, 2024device 510k629d agoFlower Orthopedics Corporation Dba Conventus Flower Ortho — OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoPAJUNK GmbH Medizintechnologie — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoXf Agencija Limited — Nooro Body & Foot Stimulator (SM9141, SM9142) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoAdvamedix, GmbH — Suction Irrigation Tubing Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoNeuvotion, Inc. — Neuvotion NeuStim NN-01 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoNova Biomedical Corporation — Nova Allegro HbA1c Assay, Nova Allegro Analyzer (510k cleared)

    Product code: LCP. Advisory committee: Hematology. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoZimmer, Inc. — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoSichuan Ast Medical Equipment Co., Ltd. — Manual Wheelchair (MASY23) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoAidite (Qinhuangdao) Technology Co., Ltd. — Additively Manufactured Denture Resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoGravitas Medical, Inc. — Entarik NI Feeding Tube System (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoAidoc Medical , Ltd. — BriefCase-Quantification (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoFemasys, Inc. — FemVue MINI Saline-Air Device (510k cleared)FEMASYS INC

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoGimbo Medical Technology Shenzhen Co., Ltd. — Giftlife® Single-Step Medium Plus (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoZhejiang Nysin Medical Co., Ltd. — Powered Wheelchair (NXN20-209) (510k cleared)Zhejiang Medicine Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoJasberry Healthcare Private Limited — Jasmate® Toothpaste (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoBeacon Biosignals, Inc. — Dreem 3S (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k629d agoCala Health, Inc. — Cala kIQ (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗

    Week of Nov 25, 2024

    25
    ›Nov 25, 2024approval626d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

    Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →lenacapavir sodium LA →fda approvals ↗
    ›Nov 25, 2024approval
    ← prev
    page 18 of 465
    next →
    626d ago
    SUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

    Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL

    full page →lenacapavir sodium LA →fda approvals ↗
    ›Nov 25, 2024device 510k626d agoHeroic Faith International , Ltd. — AccurSound Electronic Stethoscope (AS101) (510k cleared)TH International Ltd

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoSignature Orthopaedics Pty, Ltd. — World Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d ago3M Company — 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 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 ↗
    ›Nov 25, 2024device 510k626d agoZhejiang Kairui Medical Device Co., Ltd. — Electric Wheelchair (KR8803) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoDentsply Sirona, Inc. — MIS LYNX Conical Connection Implant System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoShandong Huamei Technology Co., Ltd. — EMS Sculpt Machine (510k cleared)Shandong Boan Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoScreenpoint Medical B.V. — Transpara (2.1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoHologic, Inc. — Aptima BV Assay; Aptima CV/TV Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoArum Dentistry Co., Ltd. — Customized Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoEemagine Medical Imaging Solutions GmbH — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoFH Industrie — JARVIS Glenoid Reverse Shoulder Prosthesis (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoKnox Medical Diagnostics — Aluna 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k626d agoLiquet Medical, Inc. — Versus™ Catheter (VS110-8B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024approval625d agoCHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

    Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 26, 2024approval625d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 26, 2024device 510k625d agoLVIS Corporation — NeuroMatch (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k625d agoTraferox Technologies, Inc. — LungProtect (510k cleared)TETRA TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k625d agoCirca Scientific, Inc. — Cross Wise™ Multi-Use RF Adapter Cable (510k cleared)Clear Scientific Inc

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k625d agoAtlas Spine, Inc. — Atlas Spine Lateral Expandable Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k625d agoVarian Medical Systems — Intraluminal Applicator Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k625d agoDentscare Ltda — PrimmaArt (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k625d agoRadunity Corp. — RadUnity (Version 1.0.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k625d agoColoplast Corp. — SureCath Set (510k cleared)

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

    full page →fda device 510k ↗
    $RCEL8.1200-0.98%
    $CAH234.16-2.54%
    $GILD135.87+0.07%
    $ABBV248.76-0.53%
    $FEMY
    $THCH
    $MMM
    $TTI
    $GILD135.87+0.07%
    $XRAY11.41-1.72%
    $KVUE18.98+0.74%