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24,124 catalysts · 5,000 device 510k · 4,728 grant · 4,273 approval · 3,332 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k5,000
  • grant4,728
  • approval4,273
  • 8k filing3,332
  • 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 Nov 18, 2024

    49
    ›Nov 21, 2024approval632d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: ORAL

    full page →Midol →fda approvals ↗
    ›Nov 21, 2024approval632d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

    Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval632d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

    Sponsor: BARR LABS INC. Form: TABLET. Route: ORAL

    full page →Midol →fda approvals ↗
    ›Nov 21, 2024approval632d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

    full page →hydrocodone bitartrate ER →fda approvals ↗
    ›Nov 21, 2024approval632d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

    Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval632d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Nov 21, 2024approval632d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

    Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL

    full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
    ›Nov 21, 2024approval632d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

    full page →fda approvals ↗
    ›Nov 21, 2024approval632d agoSYNALGOS-DC (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

    Sponsor: SUN PHARM INDUSTRIES. Form: CAPSULE. Route: ORAL

    full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
    ›Nov 21, 2024approval632d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024approval632d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

    full page →fda approvals ↗
    ›Nov 21, 2024approval632d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

    Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

    full page →hydrocodone bitartrate ER →fda approvals ↗
    ›Nov 21, 2024approval632d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2024device 510k632d agoFink Engineering Pty, Ltd. — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoVarian Medical Systems, Inc. — Gating Reflector Block (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoLifenet Health — PliaFX Flo (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoIlooda Co,., Ltd. — Secret MAX Multi-platform RF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoKonica Minolta, Inc. — SKR 3000 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoGM Dos Reis Industria e Comercio Ltda. — Versalock Mini and Micro Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoGeneral Vibronics, Inc. — MIRARI® Cold Plasma System ( GV-M2-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoSurGenTec, LLC — TiLink-P Joint Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d 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 510k632d agoColoplast Corp. — Luja Coude (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoJazz Imaging — Jazz Classic (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d agoCepheid® — Xpert vanA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k632d 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 510k632d 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, 2024approval631d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

    full page →teclistamab →fda approvals ↗
    ›Nov 22, 2024approval631d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

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

    full page →fda approvals ↗
    ›Nov 22, 2024approval631d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

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

    full page →fda approvals ↗
    ›Nov 22, 2024approval631d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

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

    full page →mosunetuzumab →fda approvals ↗
    ›Nov 22, 2024approval631d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 22, 2024device 510k631d 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 510k631d 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 510k631d 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 510k631d 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 510k631d agoNeuvotion, Inc. — Neuvotion NeuStim NN-01 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k631d 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 510k631d 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 510k631d 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 510k631d 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 510k631d 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 510k631d agoAidoc Medical , Ltd. — BriefCase-Quantification (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k631d 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 510k631d 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 510k631d 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 510k631d agoJasberry Healthcare Private Limited — Jasmate® Toothpaste (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k631d agoBeacon Biosignals, Inc. — Dreem 3S (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k631d 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

    1
    ›Nov 25, 2024approval628d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

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

    full page →lenacapavir sodium LA →fda approvals ↗
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    $MMSI90.76+0.29%
    $ABBV250.05-0.31%
    $BLNC
    $FEMY
    $RCEL7.9400-0.87%
    $GILD137.74-0.29%
    $ANIP75.36+0.79%
    $CAH232.78+0.67%