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5,000 catalysts · 18,987 approval · 5,443 phase readout · 5,000 device 510k · 4,728 grant · 2,630 8k filing · 2,000 device pma

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2026-08-03: 33 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 readout5,443
  • device 510k5,000
  • grant4,728
  • 8k filing2,630
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Nov 24, 2025

    24
    ›Nov 25, 2025device 510k252d agoGeistlich Pharma AG — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoZsfab, Inc. — ZSFab Lumbar Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoEsaote, S.p.A. — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoMlhealth 360 — Scaida BrainCT-ICH (v1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoSpeclipse, Inc. — BELLUS-Q (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2025device 510k252d agoLuxCreo, Inc. — LuxCreo Flexible Partial Denture Resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoMedical Wire & Equipment Company (Bath), Ltd. — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoMureva Phototherapy, Inc. — MuReva OM™ (510k cleared)

    Product code: SGQ. Advisory committee: Dental. Type: Direct

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoFrancis Medical, Inc. — Vanquish Water Vapor Ablation Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoACON Laboratories, Inc. — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoArbor Endovascular, LLC — 0.014” Willow Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoSb-Kawasumi Laboratories, Inc. — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoDentsply Sirona — CEREC Tessera Abutment System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoMgc Diagnostics Corporation — Fenom Flo™ FeNO Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoShanghai United Imaging Healthcare Co., Ltd. — uDR Arria & uDR Aris (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoTruvian Health — Tru Kidney Health Test Panel; Tru Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoLi Medical Corporation , Ltd. — RELIEEV HSG Catheter (HSG7FA1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Nov 26, 2025device 510k251d agoGe Hualun Medical Systems Co. , Ltd. — OEC One CFD (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2025device 510k250d agoOrtho Organizers, Inc. — Carriere® Motion Pro® Clear Bite Corrector (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 28, 2025device 510k249d agoBaoding Te'Anzhou Electronic Technology Co., Ltd. — Medical Diode Laser Systems (TR-B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 28, 2025device 510k249d agoDendrite Imaging, Inc. — Dendrite Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 28, 2025device 510k249d agoSophysa — Sophy Mini Monopressure Valve (SM1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 28, 2025device 510k249d agoCanon Medical Informatics, Inc. — CT VScore+ (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 1, 2025

    26
    ›Dec 1, 2025device 510k246d agoExactech, Inc. — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 1, 2025device 510k
    ← prev
    page 77 of 100
    next →
    246d ago
    Shenzhen Suyzeko Limited. — Led Light Phototherapy Bed (Pro 450/ GY-680A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 1, 2025device 510k246d agoDrägerwerk AG & Co. KGaA — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 1, 2025device 510k246d agoCanon Medical Systems Corporation — Cartesion Prime (PCD-1000A/3) V10.21 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 1, 2025device 510k246d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 1, 2025device 510k246d agoSpinal Simplicity, LLC — Minuteman® G6 MIS Fusion Plate (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 1, 2025device 510k246d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2025device 510k245d agoBecton, Dickinson and Company — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Dec 2, 2025device 510k245d 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 2, 2025device 510k245d agoChangzhou New Med Micro-Medtech Co., Ltd. — Disposable Endoscopic Injection Needles (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2025device 510k245d agoAura Wellness, LLC — Aura Wave (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2025device 510k245d agoMighty Oak Medical — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoBend IT Technologies, Ltd. — Bendit17 Microcatheter (510k cleared)TAT TECHNOLOGIES LTD

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoVoxel Ray Solutions, LLC — GentleBeam (GB1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoCoreline Soft Co., Ltd. — AVIEW Lung Nodule CAD (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoVitalograph , Ltd. — VitaloJAK Clinic (Model 7100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoInsulet Corporation — Omnipod 5 algorithm (510k cleared)INSULET CORP

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoHippoclinic — HippoMind (v1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoYadu Medical (Henan) Co., Ltd. — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k244d agoCovidien, LLC — Hugo™ RAS System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k243d agoVektor Medical, Inc. — Vektor Computational ECG Mapping System (vMap®) (510k cleared)VYCOR MEDICAL INC

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k243d agoAsustek Computer, Inc. — ASUS Ultrasound Imaging System (LU800 series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k243d agoNp Medical — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k243d agoChawla Heart Technologies, LLC — MitraPatch Mitral Valve Repair System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k243d agoSiemens Healthcare Diagnostics, Inc. — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    $XRAY14.13+5.65%
    $BSX47.76+2.19%
    $TATT
    $BDX169.24+2.19%
    $ISRG374.32+5.94%
    $PODD171.03+3.44%
    $VYCO0.06600.00%