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1,112 catalysts · 3,603 8k filing · 2,280 grant · 1,740 approval · 1,112 device 510k · 1,000 device adverse event · 815 device pma

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2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 30 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: 2 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: 1 catalyst2026-10-01: 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: 2 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: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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type: device 510k×from 2025-12-09×clear all
type
  • 8k filing3,603
  • grant2,280
  • approval1,740
  • device 510k1,112
  • device adverse event1,000
  • device pma815
device recall
597
  • earnings585
  • recall266
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 8, 2025

    43
    ›Dec 9, 2025device 510k263d agoFocused Cryo, Inc. — Focused Cryotherapy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2025device 510k263d agoGE Medical Systems SCS — Allia Moveo (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2025device 510k263d agoShofu Dental Corporation — GlasIonomer FX-LC (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2025device 510k263d agoDevilbiss Healthcare, LLC — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2025device 510k263d agoGuangzhou Longest Medical Technology Co., Ltd. — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 9, 2025device 510k263d agoTianjin Huahong Technology Co., Ltd. — Lancing device (HH-XV-T) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 9, 2025device 510k263d agoInfinitt Healthcare Co., Ltd. — INFINITT DPS (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 9, 2025device 510k263d agoDentsply Sirona — Atlantis® Abutments in Titanium (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Dec 10, 2025device 510k262d agoJeil Medical Corporation — ARIX Femur Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2025device 510k262d agoPromisemed Hangzhou Meditech Co., Ltd. — Verisafe Safety Retractable Insulin Syringes (510k cleared)Shanghai Jiao Tong University

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

    full page →fda device 510k ↗
    ›Dec 10, 2025device 510k262d agoHuxley Medical — SANSA HSAT (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 10, 2025device 510k262d agoBrainspace, Inc. — Intellidrop (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d agoA Plus Biotechnology Co., Ltd. — APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista (510k cleared)Avistone Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d agoKLS-Martin L.P. — KLS Martin Pure Pectus System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d agoMedcognetics, Inc. — CogNet AI-MT+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d agoStryker Neurovascular — Target Detachable Coil (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d ago4Web Medical, Inc. — Cervical Spine Truss System - Stand Alone (CSTS-SA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d agoO&M Halyard, Inc. — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d agoHyperflex Medical — HyperFlex® Bunion Correction System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k261d agoMim Software, Inc. — MIM – LesionID Pro (510k cleared)ASURE SOFTWARE INC

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoGuangdong Maidi Medical Co., Ltd. — Self-Seal Sterilization Pouch and Roll (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoEurosets S.R.L — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoBotiss Biomaterials GmbH — Jason membrane (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoVault Paragon Group, Inc. — VaporShield (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoCresilon, Inc. — TRAUMAGEL® 2.0 Hemostatic Gel (510k cleared)

    Product code: QSY. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoHyperfine, Inc. — Swoop® Portable MR Imaging® System (510k cleared)Hyperfine, Inc.

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoMicro-Energy Medical Technology Co., Ltd. — Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoBio Compression Systems, Inc. — Bio Arterial Deluxe (IC-BAP-DX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoZimmer Switzerland Manufacturing GmbH — Affixus® Natural Nail® Proximal Humeral System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoRemidio Innovative Solutions Private Limited — Fundus On Phone Non Mydriatic (FOP NM-10) (510k cleared)

    Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoBluewind Medical , Ltd. — Revi System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoIhealth Labs, Inc. — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoBreast-Med, Inc. — VizMark Preloaded Tissue Marker Device (VM-0001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoJJGC Indústria e Comércio de Materiais Dentários S.A. — Pterygoid Indication for GM Helix Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoDmc Importação E Exportação DE Equipamentos Ltda — Therapy US (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoIhealth Labs, Inc. — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoBard Peripheral Vascular, Inc. — EnCor EnCompass™ Breast Biopsy and Tissue Removal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoRizhao Huge Biomaterials Company, Ltd. — TopCEM Vigor SA Self-Adhesive Resin Cement (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoFujifilm Corporation — FUJIFILM Ultrasonic Endoscope EB-710US (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoExelint International, Co. — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k260d agoAnsella Therapeutics — Cerynë Intimate Care (510k cleared)Arovella Therapeutics Ltd

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

    full page →fda device 510k ↗
    ›Dec 14, 2025device 510k258d agoCadwell Industries, Inc. — Hypnos (369054-200) (510k cleared)POWELL INDUSTRIES INC

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

    full page →fda device 510k ↗

    Week of Dec 15, 2025

    7
    ›Dec 15, 2025device 510k257d agoProprio, Inc. — Paradigm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k
    ← prev
    page 1 of 23
    next →
    257d ago
    Spectrawave, Inc. — HyperVue™ Imaging System - Integrated (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k257d agoInstylla, Inc. — Tembo Embolic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k257d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k257d agoFoshan Pingchuang Medical Technology Co., Ltd. — Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k257d agoFemasys, Inc. — FemVue® Controlled Saline-Air Device (FSA-300) (510k cleared)FEMASYS INC

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k257d agoSpineology, Inc. — OptiMesh Multiplanar Expandable Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    $POWL
    $HYPR
    $ASUR8.2700+1.35%
    $XRAY11.12+0.72%
    $FEMY