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23,622 catalysts · 5,000 device 510k · 4,728 grant · 3,753 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k5,000
  • grant4,728
  • approval3,753
  • 8k filing3,350
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 13, 2025

    42
    ›Jan 16, 2025device 510k577d agoNu Eyne Co., Ltd. — ADDNOX (BPSPM1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k577d agoBiofire Diagnostics, LLC — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k577d agoAxis-Shield Diagnostics, Ltd. — Alere NT-proBNP for Alinity i Reagent Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k577d agoRoche Molecular Systems, Inc. — cobas® liat CT/NG/MG nucleic acid test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k577d agoPepper Interactive, Inc. — Pepper EMS Training System (510k cleared)PELOTON INTERACTIVE, INC.

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k577d agoPearl Digital, Inc. — Pearl Clear Aligner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k577d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025approval576d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Jan 17, 2025approval576d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

    Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

    full page →taliglucerase alfa →fda approvals ↗
    ›Jan 17, 2025approval576d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

    Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 17, 2025device 510k576d agoMED-EL Elektromedizinische Geräte GmbH — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d agoAirgas Therapeutics, LLC — ULSPIRA TS™ Nitric Oxide Therapy System (510k cleared)AUG Therapeutics LLC

    Product code: MRN. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d agoEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) — The ETHICON™ Total Energy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d agoMedos International SARL — TriALTIS™ Spine System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d agoSHENZHEN SUPERLINE TECHNOLOGY CO., LTD. — Electronic Apex Locator (Alpha Apex I) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: LQY. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d agoVarian Medical Systems, Inc. — Embozene Color-Advanced Microspheres (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d agoMedimaps Group SA — TBS iNsight (V4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d agoPrenuvo — Prenuvo Body Composition (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d 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 510k576d 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 510k576d 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 510k576d agoMilvue — TechCare Trauma (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d agoHologic, Inc. — Aptima CMV Quant Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d 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 510k576d agoMyocene — Myocene (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d agoUnity Medical, Inc. — VersaD Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k576d 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 510k574d 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

    8
    ›Jan 21, 2025approval572d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

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

    full page →mogamulizumab →fda approvals ↗
    ›Jan 21, 2025approval
    ← prev
    page 38 of 473
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    572d ago
    EPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

    full page →EPYSQLI →fda approvals ↗
    ›Jan 21, 2025approval572d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

    full page →fda approvals ↗
    ›Jan 21, 2025device 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 ↗
    $MDT91.27+0.76%
    $MMSI90.76+0.29%
    $PFE26.79-0.04%
    $PTON
    $MDT91.27+0.76%
    $FRTRY
    $MDCE0.00020.00%
    $KVUE19.200.00%
    $MMSI90.76+0.29%