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21,216 catalysts · 4,728 grant · 3,704 device 510k · 3,189 8k filing · 3,015 approval · 2,000 device pma · 2,000 device recall

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type
  • grant4,728
  • device 510k3,704
  • 8k filing3,189
  • approval3,015
  • device pma2,000
  • device recall2,000
  • device adverse event1,000
  • recall915
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Mar 17, 2025

    50
    ›Mar 19, 2025device 510k512d agoSafesource Direct, LLC — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025approval511d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

    Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

    full page →odevixibat →fda approvals ↗
    ›Mar 20, 2025approval511d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

    full page →guselkumab →fda approvals ↗
    ›Mar 20, 2025device 510k511d agoHangzhou AGS MedTech Co., Ltd. — Endoscopic Water Pump (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoHunan Haipuming Technology Co., Ltd. — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (510k cleared)

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoBoston Scientific — iSLEEVE Introducer Set (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoCardiovia , Ltd. — ViaOne Epicardial Access System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoDRTECH Corporation — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoSpectrawave, Inc. — Starlight Imaging Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoPixee Medical — Knee+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoAvatar Medical — brAIn™ Shoulder Positioning (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoRiverpoint Medical, LLC — RootMend MRR (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoShenzhen TPH Technology Co., Ltd. — Ameda GLO Wearable Breast Pump (Model W8S) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoJoylux, Inc. — Joylux Intimacy Gel (PG3100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoMeridian Bioscience, Inc. — Revogene (510k cleared)Meridian Corp

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoKyocera Medical Technologies, Inc. — Tesera-k PL System and Tesera-k XL System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k511d agoVent Creativity — Vent Creativity Knee v1.0 (Hermes) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025approval510d agoNURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

    Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →rimegepant sulfate ODT →fda approvals ↗
    ›Mar 21, 2025approval510d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

    Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 21, 2025approval510d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

    full page →OTULFI →fda approvals ↗
    ›Mar 21, 2025approval510d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: TABLET. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    ›Mar 21, 2025approval510d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    ›Mar 21, 2025approval510d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

    Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 21, 2025approval510d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

    Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 21, 2025approval510d agoQULIPTA (ATOGEPANT) — FDA approvalatogepant

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →atogepant →fda approvals ↗
    ›Mar 21, 2025device 510k510d agoAZmed — Rayvolve PTX-PE (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoSolar LS Cjsc — Medical Laser System Incanto / Evoline Platinum /Evoline (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoErbe Elektromedizin GmbH — FiAPC plus probes (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoPrismatik Dentalcraft, Inc. — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoKico Knee Innovation Company Pty Limited — ARVIS Surgical Navigation System (510k cleared)

    Product code: SBF. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoCytovale, Inc. — IntelliSep Test (CV-ICG-048) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoEdwards Lifesciences, LLC — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoNatural Cycles Nordic AB — Natural Cycles (510k cleared)

    Product code: PYT. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoVitromed GmbH — V-GRAD (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoVentris Medical — Porous Biologic Scaffold (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoSignos, Inc. — Signos Glucose Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoStryker Neurovascular — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoEpitel — REMI Remote EEG Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoTenon Medical — Catamaran SI Joint Fusion System (510k cleared)Tenon Medical, Inc.

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoDentis Co., Ltd. — ChecQ (AC100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoYukon Medical, LLC — Arisure® Closed Male Luer with Spike Adapter (YM060) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoCasebioscience, Inc. — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (510k cleared)BJ Bioscience Inc

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Electrohydraulic Lithotriptor (TCS-B3-II) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoBoston Scientific Corporation — Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoGetset Surgical, SA — GoLIF! Lumbar Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoPhilips Medizin Systeme Böblingen GmbH — Philips Holter Analysis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoStryker Instruments — Consolidated Operating Room Equipment (CORE) 2 Console (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k510d agoBecton, Dickinson and Company — BD Vacutainer® Multiple Sample Luer Adapter (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
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    $ABBV248.14-0.78%
    $GILD135.56-0.15%
    $PFE26.26-1.36%
    $MDCE0.00020.00%
    $MRBK
    $FRTRY
    $TNON0.2832-3.11%
    $EW91.33-2.47%
    $BSX51.55+0.70%
    $FMS23.72-0.63%
    $BSX51.55+0.70%
    $BDX183.25+1.02%