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21,366 catalysts · 4,728 grant · 3,844 device 510k · 3,152 8k filing · 3,046 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 45 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type
  • grant4,728
  • device 510k3,844
  • 8k filing3,152
  • approval3,046
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall931
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 24, 2025

    47
    ›Feb 26, 2025device 510k533d agoMedline Industries, LP — Medline Level 4 Surgical Gown with Breathable Sleeves (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k533d agoFovia, Inc. — aiCockpit AI Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025device 510k533d agoMaquet Cardiovascular, LLC — Vasoview Hemopro 3 Power Supply (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025approval532d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

    Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

    full page →enfortumab vedotin →fda approvals ↗
    ›Feb 27, 2025device 510k532d agoNanofiber Solutions, LLC — Rotium (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoVeol Medical Technologies Pvt , Ltd. — EzVu Visual Vasopressor injector (EV-19) (510k cleared)KESTRA MEDICAL TECHNOLOGIES, LTD.

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoXod, Inc. — XOD Diathermia Radiofrequency Device (510k cleared)Xos, Inc.

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoGleamer Sas — ChestView US (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoVascutek, Ltd. — Gelweave™ Vascular Prostheses (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoIline Microsystems, S.L. — microINR System (510k cleared)

    Product code: GJS. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoIcotec AG — VADER® Pedicle System and VADER®one Pedicle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoXaga Surgical — Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoBecton Dickinson Infusion Therapy Systems, Inc. — PIVO™ Pro Needle-free Blood Collection Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoThermo Fisher Scientific — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

    Product code: NGZ. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 27, 2025device 510k532d agoBrosmed Medical Co., Ltd. — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025approval531d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

    full page →ONTRUZANT →fda approvals ↗
    ›Feb 28, 2025approval531d agoAK-FLUOR 25% (FLUORESCEIN SODIUM) — FDA approvalLong Grove Pharmaceuticals LLC

    Sponsor: LONG GROVE PHARMS. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 28, 2025approval531d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

    Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL

    full page →(olanzapine + samidorphan l-malate) →fda approvals ↗
    ›Feb 28, 2025approval531d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

    Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →zilucoplan →fda approvals ↗
    ›Feb 28, 2025approval531d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

    Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →zilucoplan →fda approvals ↗
    ›Feb 28, 2025approval531d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

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

    full page →TYENNE →fda approvals ↗
    ›Feb 28, 2025approval531d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

    Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 28, 2025approval531d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

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

    full page →OSENVELT →fda approvals ↗
    ›Feb 28, 2025approval531d agoEPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (EPINEPHRINE BITARTRATE) — FDA approvalepinephrine bitartrate

    Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS

    full page →epinephrine bitartrate →fda approvals ↗
    ›Feb 28, 2025approval531d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

    Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 28, 2025device 510k531d agoRb Health (Us), LLC — Durex Polyisoprene Condom (510k cleared)Bausch Health US LLC

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoGt Metabolic Solutions, Inc. — MagDI System (MAG-02, DS-01) (510k cleared)Seed Health Inc

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoBasis Medical — Seclusion Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoQingdao Kingon Medical Science and Technology Co., Ltd. — Portable Oxygen Concentrator (P2-TOC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoPhenox Limited — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoShandon Diagnostics Limited — E1000 Dx Digital Pathology Solution (510k cleared)

    Product code: PSY. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoBaxter Healthcare Corporation — Intravascular Extension Sets and Accessories (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoQIAGEN GmbH — QIAstat-Dx GI Panel 2 Mini B (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoHeroic Faith International , Ltd. — Airmod (510k cleared)TH International Ltd

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoW&H Dentalwerk Bürmoos GmbH — Synea Fusion Handpieces (Intensiv & Profin) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoYoung Dental Manufacturing Co. 1, LLC — Silver Fluoride Hypersensitivity Varnish (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoIntuitive Surgical, Inc. — da Vinci SP Advanced Access Port Kit (432701) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoAnhui Jbh Medical Apparatus Co., Ltd. — Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) (510k cleared)

    Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoPhantomics, Inc. — Myomics (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoSuzhou Microport Orthorecon Co., Ltd. — MedalOne Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoQuality Electrodynamics — 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoCepheid® — Xpert C. difficile/Epi (510k cleared)

    Product code: OZN. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoShenzhen Viatom Technology Co., Ltd. — Pulse Oximeter ( PO2, PO2A, PO2B) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 28, 2025device 510k531d agoPromethean Restorative, LLC — DYNAMIS™ SI Screw System (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 3, 2025

    3
    ›Mar 3, 2025approval528d agoRIVAROXABAN — FDA approvalJohnson & Johnson Innovative Medicine

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 3, 2025approval
    ← prev
    page 7 of 428
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    528d ago
    DASATINIB — FDA approvalXspray Pharma AB

    Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 3, 2025device 510k528d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — EnergyLounger (TY-01) (510k cleared)

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

    full page →fda device 510k ↗
    $AZN157.56-0.75%
    $TMO447.81+1.31%
    $KMTS20.35+8.13%
    $ALKS49.47+0.53%
    $FMS23.70-0.71%
    $XOSWW
    $FRTRY
    $THCH
    $ISRG401.23+2.00%