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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Jan 13, 2025

    50
    ›Jan 15, 2025device 510k557d agoAlcresta Therapeutics, Inc. — RELiZORB (100300/ 100301) (510k cleared)Alcyone Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k557d agoTriMed, Inc. — TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k557d agoCaption Health, Inc. — Cardiac Guidance (510k cleared)Option Care Health, Inc.

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k557d 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 510k557d 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 510k557d agoEffortmed, LLC — EffortMed Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k557d 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 510k557d 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 510k557d 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 510k557d 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 510k557d agoZiehm Imaging GmbH — Ziehm Vision RFD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 15, 2025device 510k557d 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 510k557d 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, 2025device 510k556d 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 510k556d agoYa-Man, Ltd. — Medi Lift Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k556d 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 510k556d 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 510k556d agoVieworks Co., Ltd. — VIVIX-M (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k556d 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 510k556d agoPearl, Inc. — Second Opinion CC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k556d 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 510k556d agoNu Eyne Co., Ltd. — ADDNOX (BPSPM1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k556d 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 510k556d 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 510k556d 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 510k556d 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 510k556d agoPearl Digital, Inc. — Pearl Clear Aligner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k556d 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, 2025device 510k555d 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 510k555d 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 510k555d 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 510k555d agoMedos International SARL — TriALTIS™ Spine System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d 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 510k555d 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 510k555d agoMedimaps Group SA — TBS iNsight (V4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d agoPrenuvo — Prenuvo Body Composition (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d 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 510k555d 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 510k555d 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 510k555d agoMilvue — TechCare Trauma (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d 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 510k555d 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 510k555d 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 510k555d 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 510k555d 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 510k555d agoHologic, Inc. — Aptima CMV Quant Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k555d 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 510k555d 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 510k555d 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 510k555d 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 ↗
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    $CAH228.03+0.91%
    $MMSI74.32+1.66%
    $OPCH
    $PTON
    $UTMD69.19+0.06%
    $MMSI74.32+1.66%
    $MMSI74.32+1.66%
    $FRTRY
    $HAE
    $UTHR528.47-0.20%
    $MDT83.21+1.46%
    $MMSI74.32+1.66%
    $MDT83.21+1.46%