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5,000 catalysts · 18,987 approval · 5,627 phase readout · 5,000 device 510k · 4,728 grant · 2,761 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 49 catalysts2026-08-06: 15 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 3 catalysts2026-08-11: 2 catalysts2026-08-12: 3 catalysts2026-08-13: 2 catalysts2026-08-14: 1 catalyst2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 2 catalysts2026-08-19: 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: 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: 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: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 0 catalysts2026-10-27: 3 catalysts2026-10-28: 3 catalysts2026-10-29: 9 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 readout5,627
  • device 510k5,000
  • grant4,728
  • 8k filing2,761
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings356
  • therapy area

    no tagged catalysts yet

    Week of Jan 19, 2026

    4
    ›Jan 23, 2026device 510k195d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k195d agoElidah, Inc. — Elitone for Men (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2026device 510k194d agoVydence Medical Industria E Commercio Ltda — Vydence Family of Lasers (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2026device 510k194d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Holmium Laser Therapeutic Apparatus (HZ-40) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jan 26, 2026

    46
    ›Jan 26, 2026device 510k192d agoOutset Medical, Inc. — Tablo Hemodialysis System (PN-0008000, PN-0006000U) (510k cleared)Outset Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jan 26, 2026device 510k
    ← prev
    page 87 of 100
    next →
    192d ago
    Eyas Medical Imaging, Inc. — Ascent3T Neonatal Magnetic Resonance Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 26, 2026device 510k192d agoGe Medical Systems Information Technologies, Inc. — MAC 7 Resting ECG Analysis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k191d agoSoniquence, LLC — Reusable 3 Button Fingerswitch Wand (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k191d agoBalt USA, LLC — Optima Coil System (OptiOne Coil System) (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k191d agoInbella Medical, Inc. — InbellaIgnite RF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k191d agoBeckman Coulter, Inc. — Access anti-HAV IgM (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k191d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoEver Fortune.Ai, Co., Ltd. — Seg Pro V3 (RT-300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoNingbo Zhenhai Yihao Electronic Technology Co., Ltd. — Hand Massager (SM004D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoSterivic Medical Co., Ltd. — Sterilization Pouch/Roll (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoSleepiz AG — Sleepiz One+ (Model 2.5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoKoru Medical Systems, Inc. — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (510k cleared)KORU Medical Systems, Inc.

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoImricor Medical Systems — NorthStar™ Mapping System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoVena Medical Holdings Corp — Vena MicroAngioscope™ System (510k cleared)SELECT MEDICAL HOLDINGS CORP

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — HIGHERDOSE Body Sculptor (Model: GS-03) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoAevumed, Inc. — Aevumed PROTEKT Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoXelite Biomed , Ltd. — XeliteMed SuperM-Fix Spinal Bone Cement (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoImpediMed Limited — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoE.M.S Electro Medical Systems S.A — GBT Machine Airflow Prophylaxis Master (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d ago4Web Medical — Sacroiliac Joint Truss System (SJTS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k190d agoMedacta International S.A. — Mpact 3D Metal Implants Extension – DMLS Technology (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoDongguan Smarfody Mobility Technology Co., Ltd. — Electric Scooter (Mojo-T330) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoHR Healthcare — EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits (510k cleared)HCA Healthcare, Inc.

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoUV Smart Technologies B.V. — UV Smart D60 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoNeurophet., Inc. — Neurophet AQUA AD Plus (510k cleared)NeurOp Inc

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoZhejiang Nysin Medical Co., Ltd. — Electric Scooter (DDF100) (510k cleared)Zhejiang Medicine Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoMcnicoll Surgical, Inc. — Falco Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoTalladium España, SL — Multi-Unit DAS System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoMedicalvr B.V. — Surgical Reality Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoDongguan Smarfody Mobility Technology Co., Ltd. — Electric Scooter (Mojo-T580) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoHangzhou Hawk Optical Electronic Instruments Co., Ltd. — Medical Shaver System (Morcellator) (YSB-IIIA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoHiossen, Inc. — EK MULTI ANGLED 30 ABUTMENT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoMedtox Diagnostics, Inc. — Labcorp Fentanyl Urine Visual Test (510k cleared)Co-Diagnostics, Inc.

    Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoFresenius Medical Care Renal Therapies Group, LLC — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoConmed Corporation — Y-Knotless™ Flex Anchors (510k cleared)CONMED Corp

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

    full page →fda device 510k ↗
    ›Jan 29, 2026device 510k189d agoJiangsu Jumao X-Care Medical Equipment Co., , Ltd. — Manual Wheelchair (W50) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoHangzhou Clongene Biotech Co., Ltd. — Clungene RSV Antigen Rapid Test (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoShenzhen Peninsula Medical Group — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoSaeshin Precision Co., Ltd. — Motor Handpiece and Control Unit (SDI10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Disposable Distal End Tape Hood (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoParagonix Technologies, Inc. — BAROguard Donor Lung Preservation System (510k cleared)POET TECHNOLOGIES INC.

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoPrecision Medical Ventures, Inc. Dba Revealdx — RevealAI-Lung (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoShenzhen Jianchao Intelligent Technology Co., Ltd. — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoPrismatik Dentalcraft, Inc. — BruxZir® Shaded 16 PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k188d agoBoston Aesthetics, Inc. — Boston PICO (Boston PICO) (510k cleared)

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

    full page →fda device 510k ↗
    $OM4.5200-1.09%
    $FMS23.89-0.52%
    $CODX1.5000-0.66%
    $HCA409.59+2.21%
    $SEM16.450.00%
    $KRMD4.0650+2.65%
    $CNMD32.58+1.46%
    $POET6.7800+2.73%