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1,176 catalysts · 3,603 8k filing · 2,369 grant · 1,782 approval · 1,176 device 510k · 1,000 device adverse event · 851 device pma

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type: device 510k×from 2025-12-01×clear all
type
  • 8k filing3,603
  • grant2,369
  • approval1,782
  • device 510k1,176
  • device adverse event1,000
  • device pma851
device recall
655
  • earnings585
  • recall282
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 1, 2025

    50
    ›Dec 1, 2025device 510k271d 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 510k271d agoShenzhen 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 510k271d 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 510k271d 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 510k271d 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 510k271d 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 510k271d 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 510k270d 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 510k270d 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 510k270d 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 510k270d agoAura Wellness, LLC — Aura Wave (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2025device 510k270d 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 510k269d 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 510k269d agoVoxel Ray Solutions, LLC — GentleBeam (GB1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k269d 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 510k269d 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 510k269d agoVitalograph , Ltd. — VitaloJAK Clinic (Model 7100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k269d 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 510k269d agoHippoclinic — HippoMind (v1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2025device 510k269d 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 510k269d 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 510k268d 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 510k268d 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 510k268d 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 510k268d 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 510k268d 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 510k268d agoSc Medica — FFX Facet Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2025device 510k268d 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 510k268d 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 510k268d agoSpineology, Inc. — Spineology Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›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 ↗
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    $TATT
    $VYCO0.06600.00%
    $ISRG372.60+1.51%
    $BDX188.13-1.09%
    $PODD143.38+0.23%
    $BETA16.10+2.09%