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21,680 catalysts · 4,728 grant · 4,110 device 510k · 3,118 approval · 3,086 8k filing · 2,000 device pma · 2,000 device recall

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  • grant4,728
  • device 510k4,110
  • approval3,118
  • 8k filing3,086
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall973
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 13, 2025

    50
    ›Jan 15, 2025device 510k574d agoSunray Medical Products, Inc. — Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoSynovis Micro Companies Alliance A Subsidiary of Baxter Int — GEM ZIPCLIP (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoEffortmed, LLC — EffortMed Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoMerit Medical Systems, Inc. — Ventrax™ Delivery System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoSuzhou Minhua Medical Apparatus Supplies Co., Ltd. — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoMerit Medical Systems, Inc. — Micro Ace Gold Advanced Micro Access System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoShenzhen Deliduo Medical Technology Co.,Ltd — Electrode Pad (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoZiehm Imaging GmbH — Ziehm Vision RFD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoHaemonetics Corporation — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (510k cleared)HAEMONETICS CORP

    Product code: JPA. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k574d agoBMC Medical Co., Ltd. — Respiration Data Management Software (PAP Link PC) (510k cleared)MegaPro Biomedical Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 16, 2025approval573d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 16, 2025approval573d agoARTESUNATE — FDA approvalARTESUNATE

    Sponsor: AMIVAS. Form: POWDER. Route: INTRAVENOUS

    full page →ARTESUNATE →fda approvals ↗
    ›Jan 16, 2025approval573d agoCALQUENCE (ACALABRUTINIB MALEATE) — FDA approvalCALQUENCE

    Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

    full page →CALQUENCE →fda approvals ↗
    ›Jan 16, 2025approval573d agoCALQUENCE (ACALABRUTINIB) — FDA approvalCALQUENCE

    Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

    full page →CALQUENCE →fda approvals ↗
    ›Jan 16, 2025device 510k573d agoInmedix, Inc. — CloudHRV™ System (100-01-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d agoYa-Man, Ltd. — Medi Lift Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d agoCala Health, Inc. — Cala kIQ (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d agoWondfo USA Co, Ltd. — WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d agoVieworks Co., Ltd. — VIVIX-M (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d agoDeka Research and Development Corp. — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (510k cleared)UNITED THERAPEUTICS Corp

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d agoPearl, Inc. — Second Opinion CC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d agoStryker Instruments — System 9 Sterile Battery Container (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d agoNu Eyne Co., Ltd. — ADDNOX (BPSPM1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d 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 510k573d 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 510k573d 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 510k573d 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 510k573d agoPearl Digital, Inc. — Pearl Clear Aligner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k573d 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, 2025approval572d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jan 17, 2025approval572d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

    Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

    full page →taliglucerase alfa →fda approvals ↗
    ›Jan 17, 2025approval572d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

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

    full page →fda approvals ↗
    ›Jan 17, 2025device 510k572d 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 510k572d 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 510k572d 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 510k572d agoMedos International SARL — TriALTIS™ Spine System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k572d 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 510k572d 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 510k572d agoMedimaps Group SA — TBS iNsight (V4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k572d agoPrenuvo — Prenuvo Body Composition (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k572d 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 510k572d 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 510k572d 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 510k572d agoMilvue — TechCare Trauma (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d agoHologic, Inc. — Aptima CMV Quant Assay (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $UTMD69.19+0.06%
    $PTON
    $HAE
    $UTHR529.66-1.70%
    $MMSI89.75+0.80%
    $AZN161.91+0.30%
    $AZN161.91+0.30%
    $MMSI89.75+0.80%
    $CAH237.18+0.33%
    $PFE27.05+1.08%
    $KVUE19.03-1.04%
    $MMSI89.75+0.80%
    $MDT89.41+2.58%
    $FRTRY
    $MMSI89.75+0.80%