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1,146 catalysts · 3,603 8k filing · 2,283 grant · 1,765 approval · 1,146 device 510k · 1,000 device adverse event · 827 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 2025-12-05×clear all
type
  • 8k filing3,603
  • grant2,283
  • approval1,765
  • device 510k1,146
  • device adverse event1,000
  • device pma827
device recall
606
  • earnings585
  • recall266
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 1, 2025

    26
    ›Dec 5, 2025device 510k267d 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 510k267d 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 510k267d agoManteia Technologies Co., Ltd. — ARTAssistant (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d 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 510k267d 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 510k267d 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 510k267d agoMediclus Co., Ltd. — Any-Core (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d 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 510k267d 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 510k267d agoRestor3D, Inc. — Velora Acetabular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoRemvia — Remvia NightGuard (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d 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 510k267d 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 510k267d 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 510k267d 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 510k267d agoOverjet, Inc. — Overjet CBCT Assist (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d 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 510k267d agoSaremco Dental AG — els unibond (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoQuietLab, LLC — QuietLab Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d agoAlimetry , Ltd. — Gastric Alimetry (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d 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 510k267d 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 510k267d 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 510k267d agoOncopatch, Inc. — OncoPatch (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2025device 510k267d 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 510k267d 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

    24
    ›Dec 8, 2025device 510k264d 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 ↗
    ›Dec 8, 2025device 510k
    ← prev
    page 1 of 23
    next →
    264d ago
    Brightheart — Fetal EchoScan (v1.2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 8, 2025device 510k264d agoHeartbeam, Inc. — HeartBeam AIMIGo with 12-L ECG Synthesis Software System (510k cleared)HeartBeam, Inc.

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

    full page →fda device 510k ↗
    ›Dec 8, 2025device 510k264d agoShenzhen Comen Medical Instruments Co.,Ltd — Sequential Compression System (SCD600) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 8, 2025device 510k264d agoDegen Medical — DeGen Medical Patient Specific Implant (PSI) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 8, 2025device 510k264d agoGuangdong Ace-Tec Co., Ltd. — LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 8, 2025device 510k264d agoCeribell, Inc. — Ceribell Delirium Monitor System (510k cleared)Ceribell, Inc.

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

    full page →fda device 510k ↗
    ›Dec 8, 2025device 510k264d agoShenzhen Xiangtong Co., Ltd. — Glass Ceramic (510k cleared)

    Product code: EIH. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›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 ↗
    $BETA16.10+2.09%
    $TMO447.81+1.31%
    $DDD
    $RMD220.38+5.13%
    $CBLL19.55-2.25%
    $BEATW
    $XRAY11.12+0.72%