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5,000 catalysts · 18,987 approval · 5,539 phase readout · 5,000 device 510k · 4,728 grant · 2,730 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 18 catalysts2026-08-06: 12 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 2 catalysts2026-08-13: 2 catalysts2026-08-14: 1 catalyst2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 1 catalyst2026-09-24: 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: 0 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: 0 catalysts2026-10-20: 2 catalysts2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 0 catalysts2026-10-27: 2 catalysts2026-10-28: 1 catalyst2026-10-29: 5 catalysts2026-10-30: 3 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,539
  • device 510k5,000
  • grant4,728
  • 8k filing2,730
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings331
  • therapy area

    no tagged catalysts yet

    Week of Jan 5, 2026

    30
    ›Jan 7, 2026device 510k210d agoShenzhen Best Electronics Co., Ltd. — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoAmv Consulting, LLC — SmileInspector (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoZhongshan Xiaolan Town Senlan Electronic Factory — Fetal Doppler U8-25, U9-25 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoGE Healthcare — View (510k cleared)HCA Healthcare, Inc.

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoSpine Innovation, LLC — Titanium Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoIntelivation Technologies — Advantage-C™ Ti3D Cervical Interbody Fusion Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoSingular Health Pty, Ltd. — 3DICOM MD Cloud (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoIzenimplant Co., Ltd. — ZENEX Implant System_R-System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoTornier, Inc. — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (510k cleared)BioLight Israeli Life Sciences Ltd

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoShenzhen Med-Link Electronics Tech Co., Ltd. — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoImricor Medical Systems, Inc. — Vision-MR™ Diagnostic Catheter (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoKane Biotech, Inc. — revyve® Antimicrobial Skin and Wound Cleanser (510k cleared)IO Biotech, Inc.

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoMedtronic Minimed — MiniMed Go App (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k209d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ Totus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoAliveCor, Inc. — Corvair Monza (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoNova Biomedical Corporation — Nova Allegro UACR Assay, Nova Allegro Analyzer (510k cleared)

    Product code: CGX. Advisory committee: Clinical Chemistry. Type: Dual Track

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoFH Industrie — JARVIS Metaphyseal Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoSuzhou Sweetrich Vehicle Industry Technology Co., Ltd. — Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoMedacta International S.A. — NextAR Hip Platform (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoIotamotion, Inc. — iotaSOFT® Insertion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoNingbo Ranor Medical Technology Co., Ltd. — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoUnimed Medical Supplies, Inc. — Disposable Neonatal NIBP Cuff (U1681S-C51N) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoFresenius Kabi AG — KabiHelp® Uno; KabiHelp® Advance plus (510k cleared)Fresenius Kabi USA LLC

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoSolo Pace, Inc. — Solo Pace Fusion System (SOLOFUSE1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoLiaoning Upcera Co., Ltd. — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series (510k cleared)

    Product code: EIH. Advisory committee: Dental. Type: Special

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoTruvian Health — Core Metabolic (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoEthicon Endo-Surgery, LLC — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoInstrumentation Laboratory (IL) Co. — HemosIL Silica Clotting Time (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k208d agoGI Windows, Inc. — Self-Forming Magnet (Flexagon Plus OTOLoc) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 11, 2026device 510k206d agoAlphatec Spine, Inc. — SafeOp 3: Neural Informatix System (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jan 12, 2026

    20
    ›Jan 12, 2026device 510k205d agoArthrex, Inc. — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k
    ← prev
    page 84 of 100
    next →
    205d ago
    Promethean Restorative, LLC — DYNAMIS™ Navigation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoFoshan Topmed Dental Co., Ltd. — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoEmpower Ride, LLC — EmpowerRide NAVIGATOR (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoFoshan Topmed Dental Co., Ltd. — High speed air turbine handpiece (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoBeatles Medical Supplies (Xiantao) Co., Ltd. — Disposable Surgical Face Mask (3P00B, C2900) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoDentalez, Inc., Stardental Division — Star E900 Electric System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoShenzhen Hingmed Medical Instrument Co., Ltd. — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoSioxmed, LLC — SBC1 Cream (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoBoston Aesthetics, Inc. — Boston iFace (Boston iFace) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoPrecision AI Pty, Ltd. — Precision AI Surgical Planning System (PAI-SPS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoMediclus Co., Ltd. — Any-Paste (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoTheotclab Healthcare B.V. — Dr. Yglo Skin Tag Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k205d agoSonomotion, Inc. — Break Wave (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k204d agoMiach Orthopaedics, Inc. — BEAR® (Bridge-Enhanced ACL Restoration) Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k204d agoSpinal Resources, Inc. — Swedge™ Pedicle Screw Fixation System Bezier Rod (510k cleared)RGC RESOURCES INC

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k204d agoSpectrum Dynamics Medical, Ltd. — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k204d agoDmp Dental Industry S.A. — Bright Cavity Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k204d agoStryker Endoscopy — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k204d agoKossan International Sdn Bhd — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    $IOBTQ
    $HCA400.73-1.45%
    $MMSI85.82+0.34%
    $RGCO