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1,169 catalysts · 3,312 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma

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type: device 510k×from 2025-12-02×clear all
type
  • 8k filing3,312
  • grant2,283
  • approval1,778
  • device 510k1,169
  • device adverse event1,000
  • device pma849
device recall
655
  • earnings584
  • recall282
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 1, 2025

    49
    ›Dec 2, 2025device 510k256d 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 510k256d 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 510k256d 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 510k256d agoAura Wellness, LLC — Aura Wave (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2025device 510k256d 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 510k255d 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 510k255d agoVoxel Ray Solutions, LLC — GentleBeam (GB1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k255d 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 510k255d 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 510k255d agoVitalograph , Ltd. — VitaloJAK Clinic (Model 7100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k255d 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 510k255d agoHippoclinic — HippoMind (v1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k255d 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 510k255d 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 510k254d 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 510k254d 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 510k254d 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 510k254d 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 510k254d 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 ↗
    ›Dec 4, 2025device 510k254d agoSc Medica — FFX Facet Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k254d agoTigon Medical — Tigon Medical Knotless and Dual Javelin All-Suture Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k254d agoZhejiang Taotao Vehicle Co., Ltd. — Mobility Scooter (T5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k254d agoSpineology, Inc. — Spineology Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoBlue Belt Technologies, Inc. — REAL INTELLIGENCE™ CORI™ XT (CORI XT) (510k cleared)BETA Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. — Augmented Gingival Matrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoManteia Technologies Co., Ltd. — ARTAssistant (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoDornier Medtech America Inc (Dmta) — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoKarl Storz SE & CO. KG — KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoEpic Medical Pte. , Ltd. — ProSeal™ Transfer Injector (421120, 421130, 421140) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoMediclus Co., Ltd. — Any-Core (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoLincotek Medical — SpineLinc Anterior Cervical Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoJiangsu Jumao X-Care Medical Equipment Co., , Ltd. — Manual Wheelchair (W45) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoRestor3D, Inc. — Velora Acetabular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoRemvia — Remvia NightGuard (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoJiangsu Jumao X-Care Medical Equipment Co., , Ltd. — Manual Wheelchair (W47) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoMedspira, LLC — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoNanjing Kangni Smart Technology Co., Ltd. — Electrically powered wheelchair (KZ301B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoShenzhen Siken 3D Technology Development Co., Ltd. — Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoOverjet, Inc. — Overjet CBCT Assist (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoHuinno Co., Ltd. — MEMO Patch M (MPT-E08R-UNC01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoSaremco Dental AG — els unibond (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoQuietLab, LLC — QuietLab Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoAlimetry , Ltd. — Gastric Alimetry (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoSonoscape Medical Corp. — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d ago3D Systems, Inc. — VSP Orthopedics System (510k cleared)3D SYSTEMS CORP

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoW.O.M. World of Medicine GmbH — PUREVUE™ FMS (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoOncopatch, Inc. — OncoPatch (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoThermo Fisher Scientific (Oxoid Ltd.) — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k253d agoResmed Corp — Personalized Therapy Comfort Settings (PTCS) (510k cleared)RESMED INC

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

    full page →fda device 510k ↗

    Week of Dec 8, 2025

    1
    ›Dec 8, 2025device 510k250d agoFoshan Dahao Medical Technology Co., Ltd. — Electric Wheelchair (DH01126) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
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    $BDX183.29+0.73%
    $TATT
    $ISRG401.270.00%
    $TMO447.81+1.31%
    $RMD220.38+5.13%
    $VYCO0.06600.00%
    $DDD
    $PODD146.44+0.95%
    $BETA16.10+2.09%