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1,517 catalysts · 3,288 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma

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type: device 510k×from 2025-10-21×clear all
type
  • 8k filing3,288
  • grant2,401
  • approval2,188
  • device 510k1,517
  • device recall1,123
  • device pma1,026
device adverse event
1,000
  • earnings584
  • recall391
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 20, 2025

    50
    ›Oct 21, 2025device 510k297d agoOlympus Medical Systems Corporation — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoMIPM Mammendorfer Institut für Physik und Medizin GmbH — Neuromuscular Transmission Monitor TOF3D (2510091) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoAstura Medical — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoSimplivia Healthcare , Ltd. — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoMedivis, Inc. — NeuroAlign software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoMedos International SARL — TriALTIS™ Spine System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoEdwards Lifesciences — HemoSphere Stream Module (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoBodycad Laboratories, Inc. — Fine TTO™ (510k cleared)Barr Laboratories Inc

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoAevumed, Inc. — Aevumed FASE Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoCardiocycle Medical(Suzhou) Co., Ltd. — Introducer Sheath Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k297d agoLivsmed, Inc. — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoProsidyan, Inc. — FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoYorlabs, Inc. — XC11 ICE System, USA (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoZeus Scientific — Alegria Flash CTD Screen (510k cleared)Dawn Sea Therapeutics

    Product code: LLL. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoImeka Solutions, Inc. — ANDI 2.0 (510k cleared)UL Solutions Inc.

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoQIAGEN GmbH — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoGenesys Spine — SIros-X System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoCosmo Far East Technology Limited — Hair Growth Laser Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoDatex-Ohmeda, Inc. — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoDcstar, Inc. — Mandibular Advancement Device L07 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoRti Surgical, Inc. — Pre-Sutured Tendon (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoACON Laboratories, Inc. — Flowflex Plus RSV + Flu A/B + COVID Home Test (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoSirona Medical — Sirona Advanced Imaging Suite (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoNingbo Youhe Electrical Appliance Technology Co., Ltd. — electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoIntervene — Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoMaxx Orthopedics, Inc. — Freedom® Total Knee System – Titan PCK Components (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoBalt USA, LLC — Carrier XL Delivery Catheter (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k296d agoGuangzhou Wondfo Biotech Co., Ltd. — WELLlife COVID-19 Antigen Test Rx (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoVivasure Medical Limited — PerQseal Introducers (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoAlign Technology, Inc. — Invisalign® Palatal Expander System (510k cleared)ALIGN TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoAsclepion Laser Technologies GmbH — MultiPulse TFL (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoHartalega NGC Sdn. Bhd. — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoSa3, LLC — Silatrix Oral Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoRisu Medical Technology Co., Ltd. — Picosecond Laser Device (PF131-BI) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoTerrats Medical SL — DESS® Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoUroviu Corporation — UV5000W Handle (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 23, 2025device 510k295d agoTerarecon,Inc. — TeraRecon Cardiovascular.Calcification.CT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoCoroventis Research AB — CoroFlow Cardiovascular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoBeijing Fule Science & Technology Development Co., Ltd. — Fule Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ Spinal System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoPhilips Medical Systems Nederland B.V. — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoVesalio, Inc. — Vesalio Peripheral System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoOlympus Medical Systems Corp. — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoDexcowin Global, Inc. — Cocoon Solo (DX-7020s) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoMedivance, Inc. — Arctic Sun Temperature Management System (Model 5000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoAbbott Ireland — Glucose2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoPhilips Medical Systems B.V. — Azurion R3.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 24, 2025device 510k294d agoSpectrum Spine, Inc. — Expandable Titanium PLIF/TLIF System (510k cleared)

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

    full page →fda device 510k ↗
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