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21,759 catalysts · 4,728 grant · 4,110 device 510k · 3,153 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 46 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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  • grant4,728
  • device 510k4,110
  • 8k filing3,153
  • approval3,118
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall985
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 13, 2025

    26
    ›Jan 17, 2025device 510k573d agoMedimaps Group SA — TBS iNsight (V4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoPrenuvo — Prenuvo Body Composition (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoOlympus Medical Systems Corporation — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoMED-EL Elektromedizinische Geräte GmbH — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (510k cleared)

    Product code: ETB. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoRoche Molecular Systems, Inc. — cobas® liat CT/NG nucleic acid test (510k cleared)

    Product code: QEP. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoMilvue — TechCare Trauma (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoMedtronic, Inc. — Affera Integrated Mapping System (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoSofradim Production — ProGrip™ Self-Gripping Polypropylene Mesh (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoDraeger Medical Systems, Inc. — Babyroo TN300 (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoSonoscape Medical Corp. — Digital Color Doppler Ultrasound System (P60 Series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoKoh Young Technology, Inc. — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoHologic, Inc. — Aptima CMV Quant Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoPhilips Medizin Systeme Böblingen GmbH — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoAmb Medtec — hygh-tec Drainage II (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoMedtronic, Inc. — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoAccess Vascular, Inc. — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoMED-EL Elektromedizinische Geräte GmbH — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (510k cleared)

    Product code: ETA. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoWilson-Cook Medical, Inc. — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoMedtronic Sofamor Danek, Inc. — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoSmart Denture Conversions, LLC — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) (510k cleared)

    Product code: NHA. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoGe Medical Systems Israel, Functional Imaging — Aurora (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoNeoventa Medical AB — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoMyocene — Myocene (510k cleared)

    Product code: SDX. Advisory committee: Neurology. Type: Direct

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoUnity Medical, Inc. — VersaD Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k573d agoTrue Indicating, LLC — Type 5 Integrating Indicator for Steam (CSPN-15) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 19, 2025device 510k571d agoNavi Medical Technologies — Neonav ECG Tip Location System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗

    Week of Jan 20, 2025

    24
    ›Jan 21, 2025approval569d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

    Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION

    full page →mogamulizumab →fda approvals ↗
    ›Jan 21, 2025approval
    ← prev
    page 5 of 436
    next →
    569d ago
    EPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

    full page →EPYSQLI →fda approvals ↗
    ›Jan 21, 2025approval569d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

    full page →fda approvals ↗
    ›Jan 21, 2025device 510k569d agoMedical Brands Laboratories B.V. — Advanced Cryo Wart Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k569d agoWontech Co., Ltd. — Oligio X (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k569d agoHathor Professional Skincare , Ltd. — Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k569d agoShenzhen HugeMed Medical Technical Development Co., Ltd. — Biliary Pancreaticobiliary Scope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k569d agoPrecision AI Pty, Ltd. — Precision AI Surgical Planning System (PAI-SPS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2025device 510k569d agoZiehm Imaging GmbH — Ziehm Vision RFD 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2025approval568d agoHALOPERIDOL — FDA approvalHALOPERIDOL

    Sponsor: AIPING PHARM INC. Form: TABLET. Route: ORAL

    full page →HALOPERIDOL →fda approvals ↗
    ›Jan 22, 2025approval568d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

    Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL

    full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗
    ›Jan 22, 2025approval568d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

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

    full page →fda approvals ↗
    ›Jan 22, 2025approval568d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

    Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Jan 22, 2025approval568d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2025approval568d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Jan 22, 2025approval568d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

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

    full page →(olanzapine + samidorphan l-malate) →fda approvals ↗
    ›Jan 22, 2025approval568d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

    Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →aripiprazole LA →fda approvals ↗
    ›Jan 22, 2025approval568d agoRYKINDO (RISPERIDONE) — FDA approvalDelpor Inc

    Sponsor: SHANDONG LUYE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Jan 22, 2025approval568d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

    Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL

    full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗
    ›Jan 22, 2025approval568d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

    Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL

    full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗
    ›Jan 22, 2025approval568d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: TABLET. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    ›Jan 22, 2025approval568d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    ›Jan 22, 2025approval568d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jan 22, 2025approval568d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

    Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    $MDCE0.00020.00%
    $MDT90.02-0.73%
    $MMSI90.59-0.57%
    $MDT90.02-0.73%
    $TEVA36.64+0.44%
    $RDY12.39-0.49%
    $ALKS49.47+0.53%
    $TEVA36.64+0.44%