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21,783 catalysts · 4,728 grant · 4,110 device 510k · 3,189 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall

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  • grant4,728
  • device 510k4,110
  • 8k filing3,189
  • approval3,118
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall973
  • 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, 2025recall512d agoAspen Biopharma Labs Pvt., Ltd. recall (Cls II)Greenstone LLC

    Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. — Reason: CGMP Deviations — Status: Ongoing

    full page →fda recalls ↗
    ›Mar 19, 2025device 510k512d agoNanosonics Limited — CORIS System (510k cleared)

    Product code: SEW. Advisory committee: General Hospital. Type: Direct

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoCoreline Soft Co., Ltd. — AVIEW (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoCampomats S.R.L. — 1NEED Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoTyber Medical, LLC — Tyber Medical Anatomical Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoShenzhen Yang WO Electronic Co., Ltd. — IPL Hair Removal Device (BE965A, BE965B, BE965C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoDRTECH Corporation — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoMacromedics BV — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoOlympus Medical Systems Corporation — Luer-Split MAJ-2092 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoTriMed, Inc. — TriMed Ankle Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoTriMed, Inc. — TriMed Elbow and Forearm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoMustech Electronics Co., Limited — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoShenB Co., Ltd. — Sunny (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoScivita Medical Technology Co., Ltd. — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) (510k cleared)NewBay Medical Technology Co Ltd

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k512d agoAcurable Limited — AcuPebble Ox (200) (510k cleared)

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

    full page →fda device 510k ↗
    ›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 ↗
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    $BSX51.42+0.45%
    $FRTRY
    $MRBK
    $GILD135.87+0.07%
    $ABBV248.76-0.53%
    $MDCE0.00020.00%
    $FMS23.72-0.63%
    $PFE26.31-1.16%
    $EW91.33-2.47%