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23,140 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k4,900
  • grant4,728
  • approval3,532
  • 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 Oct 28, 2024

    50
    ›Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 31, 2024approval651d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 31, 2024approval651d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

    full page →fda approvals ↗
    ›Oct 31, 2024approval651d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

    Sponsor: APOTEX. Form: SPRAY, METERED. Route: NASAL

    full page →BUTORPHANOL TARTRATE →fda approvals ↗
    ›Oct 31, 2024approval651d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 31, 2024approval651d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 31, 2024approval651d agoLEVORPHANOL TARTRATE — FDA approvalLEVORPHANOL TARTRATE

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

    full page →LEVORPHANOL TARTRATE →fda approvals ↗
    ›Oct 31, 2024approval651d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: ANDA REPOSITORY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 31, 2024approval651d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

    Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: MIKART. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 31, 2024approval651d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 31, 2024approval651d agoLEVORPHANOL TARTRATE — FDA approvalSpecGx LLC

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

    full page →fda approvals ↗
    ›Oct 31, 2024approval651d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 31, 2024approval651d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Oct 31, 2024approval651d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2024approval651d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: AVANTHI INC. Form: CAPSULE. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2024device 510k651d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — V80 Anesthetic Vaporizer (V80) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k651d agoBard Access Systems, Inc. — PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (510k cleared)

    Product code: LJT. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k651d agoBecton, Dickinson and Company — BD Vacutainer® Citrate Blood Collection Tubes (510k cleared)BECTON DICKINSON & CO

    Product code: GIM. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k651d agoSmartcardia SA — SmartCardia 7L Platform (MCT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k651d agoBonebridge AG — Bonebridge Osteosynthesis Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k651d agoHighness Co., Ltd. — Highness Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k651d agoShenzhen Medke Technology Co., Ltd. — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k651d agoErad, Inc. — eRAD PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 31, 2024device 510k651d agoBionova Medical, Inc. — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024approval650d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 1, 2024approval650d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

    Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

    full page →dulaglutide →fda approvals ↗
    ›Nov 1, 2024approval650d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

    Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

    full page →dulaglutide →fda approvals ↗
    ›Nov 1, 2024approval650d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

    Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Toujeo LA →fda approvals ↗
    ›Nov 1, 2024approval650d agoADLYXIN (LIXISENATIDE) — FDA approvalADLYXIN

    Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ADLYXIN →fda approvals ↗
    ›Nov 1, 2024approval650d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 1, 2024approval650d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 1, 2024approval650d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›Nov 1, 2024approval650d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›Nov 1, 2024approval650d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›Nov 1, 2024approval650d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 1, 2024approval650d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Saxenda →fda approvals ↗
    ›Nov 1, 2024approval650d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 1, 2024device 510k650d agoWright Medical Technology, Inc. (Stryker) — Prophecy Surgical Planning System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoMedtronic, Inc. — Affera Integrated Mapping System; Impedance Localization Patch Kit (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoShanghai United Imaging Healthcare Co., Ltd. — uDR 780i (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoBecton, Dickinson and Company — BD Vacutainer® One Use Holder (510k cleared)BECTON DICKINSON & CO

    Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoQuanta Dialysis Technologies, Ltd. — SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoCovidien (Part of Medtronic) — Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoFujifilm Corporation — Over-tube (TR-1108A) (510k cleared)Fujifilm Holdings Corp

    Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoGM Dos Reis Industria e Comercio Ltda. — EXPERT - Flexible Joint Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoDRTECH Corporation — XERO-alpha (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoPollogen, Ltd. — Legend X Desktop System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoDepuy Orthopedics, Inc. — DePuy ATTUNE™ Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 1, 2024device 510k650d agoBaylis Medical Company — VersaCross™ RF Wire (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
    page 11 of 463
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    $FRTRY
    $BDX183.25+1.02%
    $AMRX17.52+2.43%
    $LLY1214.72-0.02%
    $LLY1214.72-0.02%
    $AVTR13.80+0.25%
    $LLY1214.72-0.02%
    $LLY1214.72-0.02%
    $IGC0.2670+0.41%
    $NIU2.0700+3.50%
    $LLY1214.72-0.02%
    $NVO46.20-2.06%
    $MDT90.76+0.09%
    $BDX183.25+1.02%