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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,627 8k filing · 2,000 device pma

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2026-08-03: 28 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 filing2,627
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Nov 17, 2025

    24
    ›Nov 20, 2025device 510k257d agoProvidence Medical Technology, Inc. — CORUS-LX Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoHangzhou Kangji Medical Instrument Co., Ltd. — Disposable Polymer Ligation Clips (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoIntegrated Endoscopy, Inc. — Nuvis® Wireless HD Camera System (Nuvis-2K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoMedline Industries, LP — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2025device 510k257d agoSiemens Shenzhen Magnetic Resonance , Ltd. — MAGNETOM Free.Max; MAGNETOM Free.Star (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoEffortmed, LLC — EffortMed PEEK Cages & Corpectomy Cages (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoNGMedical GmbH — BEE HA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoNeuro Event Labs OY — Nelli (Version 7.11) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoDeroyal Industries, Inc. — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory (510k cleared)ABM INDUSTRIES INC /DE/

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoFoshan Kycare Medical Equipment Co., Ltd. — Oxygen Concentrator (J5A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoGraphy, Inc. — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoCentrix, Inc. — FluoroDose Varnish (510k cleared)CentricsBio Inc

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoJoint Preservation Innovations, LLC — Articulator Arthroscopic Bur (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoEveryway Medical Instruments Co.,Ltd — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoStaclear, Inc. — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoTerumo Corporation — Pen Injector Needle 32.5 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoPhasor Health, LLC — LEGACY (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Manual Wheelchair (HM305-Air1, HM305-Air2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoIcardio.Ai — CardioVision (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoArchy Dental, Inc. — Archy Dental Imaging (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoIntradin (Shanghai) Machinery Co., Ltd. — Powered Mobility Scooter (PMS105, GUT177, GCAT047) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoCeribell, Inc. — Ceribell Infant Seizure Detection Software (510k cleared)Ceribell, Inc.

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

    full page →fda device 510k ↗
    ›Nov 21, 2025device 510k256d agoDentsply Sirona — Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Nov 22, 2025device 510k255d agoKarl Storz SE & CO. KG — KARL STORZ Cholangiography Set (510k cleared)

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

    full page →fda device 510k ↗

    Week of Nov 24, 2025

    26
    ›Nov 24, 2025device 510k253d agoPrecision Spine, Inc. — Dakota LP System (510k cleared)Precision Dose Inc

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k
    ← prev
    page 76 of 100
    next →
    253d ago
    Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoLaerdal Medical AS — The BAG manual resuscitator and accessories (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoAngioDynamics, Inc. — AlphaVac Multipurpose Mechanical Aspiration System F1885 (510k cleared)ANGIODYNAMICS INC

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoEurosets S.R.L — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoF Care Systems USA, LLC — F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoA2z Radiology Ai, Inc. — a2z-Unified-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoVesalio, Inc. — NeVa PV Thrombectomy Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoBozhou Rongjian Medical Appliance Co., Ltd. — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 24, 2025device 510k253d agoFresenius Medical Care Renal Therapies Group, LLC — BCM2-Body Composition Monitor (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoOlympus Medical Systems Corporation — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoIndica Labs, LLC — HALO AP Dx (510k cleared)

    Product code: QKQ. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoEncore Guards — enCore Night Guard (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoStemtech Medical Devices Private Limited — Eva Scalp Cooling System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoAkura Medical — Akura Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoGood Sleep CO Pte , Ltd. — Hushd Avera (510k cleared)

    Product code: LRK. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoUzinmedicare Co., Ltd. — Spectra Platinum (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoTrustees of the University of Pennsylvania — PennPET Explorer Positron Emission Tomograph (510k cleared)University of Pennsylvania

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoShenzhen Leaflife Technology Co., Ltd. — LeafPure-Echo (LM-LPNdA) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoRay Co., Ltd. — RCT700 (510k cleared)Ray Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoFeops NV — FEops HEARTguide Simulation Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoMedusa Orthopedics, LLC — Medusa Orthopedics Boa External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoDongguan Lide Electric Appliance Co., Ltd. — IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoNaox Technologies Sas — NX01 (NX01) (510k cleared)Niu Technologies

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

    full page →fda device 510k ↗
    $CBLL19.55-2.25%
    $XRAY13.37-2.69%
    $FRTRY
    $NIU2.59000.00%
    $FMS25.66-0.16%
    $ANGO13.82-2.81%
    $ABM