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22,939 catalysts · 4,728 grant · 4,552 device 510k · 3,668 8k filing · 3,228 approval · 2,000 device pma · 2,000 device recall

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type
  • grant4,728
  • device 510k4,552
  • 8k filing3,668
  • approval3,228
  • device pma2,000
  • device recall2,000
recall
1,098
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Nov 18, 2024

    28
    ›Nov 21, 2024device 510k651d agoShenzhen Smallsignal Technology Co., Ltd. — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k651d agoColoplast Corp. — Luja Coude (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k651d agoJazz Imaging — Jazz Classic (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k651d agoCepheid® — Xpert vanA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k651d 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 510k651d 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, 2024approval650d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

    full page →teclistamab →fda approvals ↗
    ›Nov 22, 2024approval650d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

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

    full page →fda approvals ↗
    ›Nov 22, 2024approval650d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

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

    full page →fda approvals ↗
    ›Nov 22, 2024approval650d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

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

    full page →mosunetuzumab →fda approvals ↗
    ›Nov 22, 2024approval650d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 22, 2024device 510k650d 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 510k650d 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 510k650d 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 510k650d 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 510k650d agoNeuvotion, Inc. — Neuvotion NeuStim NN-01 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k650d 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 510k650d 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 510k650d 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 510k650d 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 510k650d 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 510k650d agoAidoc Medical , Ltd. — BriefCase-Quantification (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k650d 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 510k650d 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 510k650d 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 510k650d agoJasberry Healthcare Private Limited — Jasmate® Toothpaste (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k650d agoBeacon Biosignals, Inc. — Dreem 3S (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k650d 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

    22
    ›Nov 25, 2024approval647d 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 3 of 459
    next →
    647d 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 510k647d 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 510k647d agoSignature Orthopaedics Pty, Ltd. — World Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k647d 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 510k647d 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 510k647d 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 510k647d 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 510k647d 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 510k647d 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 510k647d agoArum Dentistry Co., Ltd. — Customized Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k647d 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 510k647d 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 510k647d agoKnox Medical Diagnostics — Aluna 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k647d agoLiquet Medical, Inc. — Versus™ Catheter (VS110-8B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024approval646d agoCHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

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

    full page →fda approvals ↗
    ›Nov 26, 2024approval646d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 26, 2024device 510k646d agoLVIS Corporation — NeuroMatch (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2024device 510k646d 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 510k646d 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 510k646d 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 510k646d agoVarian Medical Systems — Intraluminal Applicator Set (510k cleared)

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

    full page →fda device 510k ↗
    $RCEL10.07-0.30%
    $FEMY
    $CAH239.35+2.02%
    $ABBV259.99+1.39%
    $GILD149.92+2.45%
    $XRAY10.76-3.67%
    $THCH
    $GILD149.92+2.45%
    $MMM
    $TTI
    $KVUE18.75-0.69%