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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,622 8k filing · 2,000 device pma

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2026-08-03: 23 catalysts2026-08-04: 13 catalysts2026-08-05: 18 catalysts2026-08-06: 11 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: 1 catalyst2026-08-14: 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: 0 catalysts2026-09-24: 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: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 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: 3 catalysts2026-10-30: 0 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,622
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Nov 10, 2025

    8
    ›Nov 14, 2025device 510k263d agoOnward Medical, Inc. — ARC-EX System (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k263d agoQingdao Future Medical Technology Co., Ltd. — Mesh Nebulizer (H6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k263d agoEos Imaging — AutoDensity (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k263d agoBiomoneta Research Private Limited — Biomoneta Avata Rx (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k263d agoFusmobile, Inc. — Neurolyser XR (NXR100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k263d agoPearl, Inc. — Second Opinion® Panoramic (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k263d agoInanovate, Inc. — Lyme-ID IgG Test; Bio-ID800 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 14, 2025device 510k263d agoAlovea Healthcare Co. , Ltd. — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗

    Week of Nov 17, 2025

    42
    ›Nov 17, 2025device 510k260d agoPiccolo Medical, Inc. — PM2™ System with ECGuide™ Connector (510k cleared)Picard Medical, Inc.

    Product code: LJS. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Nov 17, 2025device 510k
    ← prev
    page 75 of 100
    next →
    260d ago
    Nobel Biocare C/O Medicim NV — DTX Studio Assist (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 17, 2025device 510k260d agoSiemens Medical Solutions USA, Inc. — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 17, 2025device 510k260d agoMercator Medical (Thailand), Ltd. — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Nov 17, 2025device 510k260d agoBeckman Coulter, Inc. — Access Rubella IgG (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 17, 2025device 510k260d agoStarmed Co., Ltd. — TS-RF Generator (STS10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 17, 2025device 510k260d agoNox Medical Ehf — DeepRESP (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoGuangzhou Wondfo Biotech Co., Ltd. — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoCollagen Matrix, Inc. — Collagen Dura Regeneration Membrane - Repair (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoUlrich GmbH & Co. KG — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoDouble Medical Technology, Inc. — Universal Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoNvision Biomedical Technologies, Inc. — ToeJack MIS Bunion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoPrismatik Dentalcraft, Inc. — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoKarl Storz SE & CO. KG — Miniature Telescope for Urology (27033AA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoSuretex Limited — LifeStyles® HydraFeel Natural Rubber Latex Condom (510k cleared)

    Product code: HIS. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoDexcom, Inc. — Dexcom Smart Basal (510k cleared)DEXCOM INC

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoThe Surgical Company International B.V. — Fluido Compact System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2025device 510k259d agoCarre Technologies, Inc. — Hexoskin Medical System (7100-00016) (510k cleared)Q/C TECHNOLOGIES, INC.

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoCytovale, Inc. — IntelliSep Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoMedacta International S.A. — MyPAO SA guides (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoFisher & Paykel Healthcare, Ltd. — OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoDepuy Ireland UC — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoFusion Innovations, LLC — SternaFuse Ti Fixation System (510k cleared)Fundrise Innovation Fund, LLC

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoShenzhen Dachi Communication Co., Ltd. — Microcurrent Facial Device (CEC101, EEI101) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoEdap Technomed, Inc. — Focal One® (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoGu'An Yeolight Smart Electronics Co., Ltd. — IPL Hair Removal Device (SYL001AZ, SYL002AZ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoHuizhou Foryou Medical Devices Co., Ltd. — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoSunglor Technology Co., Ltd. — LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Nov 19, 2025device 510k258d agoVarian Medical Systems — Guided Aarhus Applicator Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoResponse Ortho Solutions, LLC — The Response Ortho Smart Fixator - Hexapod System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoSi Solutions, LLC — OptumSI Implant System (510k cleared)Evita Solutions LLC

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoRemington Medical, Inc. — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoGuangzhou Heygears IMC., Inc. — UltraPrint-Dental Denture UV (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoClassys, Inc. — CuRAS hybrid (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoHardy Diagnostics — HardyDisk AST Cefiderocol 30µg (FDC30) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoRoche Molecular Systems, Inc. — cobas liat Bordetella panel nucleic acid test (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoSiemens Healthineers AG — syngo.MR Applications (VB80) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoCosylab Jsc, Control System Laboratory — PlanOne 1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoShalby Advanced Technologies, Inc. Dba Consensus Orthopedics — TaperSet™ Hip System (510k cleared)

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

    full page →fda device 510k ↗
    $PMI0.1821-4.66%
    $PMI0.1821-4.66%
    $DXCM83.45+11.95%
    $QCLS
    $VCX
    $VIOT