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5,000 catalysts · 18,987 approval · 5,443 phase readout · 5,000 device 510k · 4,728 grant · 2,667 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 13 catalysts2026-08-05: 18 catalysts2026-08-06: 12 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: 2 catalysts2026-08-14: 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 readout5,443
  • device 510k5,000
  • grant4,728
  • 8k filing2,667
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Dec 8, 2025

    31
    ›Dec 11, 2025device 510k236d 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 510k236d 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 510k236d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k236d agoMedcognetics, Inc. — CogNet AI-MT+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k236d agoStryker Neurovascular — Target Detachable Coil (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k236d 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 510k236d 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 510k236d agoHyperflex Medical — HyperFlex® Bunion Correction System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 11, 2025device 510k236d 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 510k235d 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 510k235d 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 510k235d agoBotiss Biomaterials GmbH — Jason membrane (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k235d agoVault Paragon Group, Inc. — VaporShield (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d agoBluewind Medical , Ltd. — Revi System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2025device 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k235d 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 510k233d 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

    19
    ›Dec 15, 2025device 510k232d 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 79 of 100
    next →
    232d 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 510k232d agoInstylla, Inc. — Tembo Embolic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k232d 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 510k232d 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 510k232d 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 510k232d agoSpineology, Inc. — OptiMesh Multiplanar Expandable Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k232d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k232d agoMachina Medical, Inc. — MFUSE (MS001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k232d agoArgon Medical Devices, Inc. — V•Stick™ Vascular Access Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k232d agoSleepres, Inc. — SleepRes PAP System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 15, 2025device 510k232d agoErchonia Corporation — Erchonia CLX (Model # CFL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoFujirebio Diagnostics,Inc. — ADVIA Centaur Cytokeratin Fragment 21-1 (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoPentax of America, Inc. — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoIntuitive Surgical, Inc. — IRISeg (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoBaxter Healthcare Corporation — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoSpectrum Vascular — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoCmr Surgical Limited — Versius Surgical System (Versius Plus) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoZhejiang Geyi Medical Instrument Co., Ltd. — Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) (510k cleared)

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

    full page →fda device 510k ↗
    $HYPR
    $ASUR8.2700+1.35%
    $POWL
    $CODX1.4800+2.78%
    $ISRG375.41+6.25%
    $ISRG375.41+6.25%
    $FEMY