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885 catalysts · 3,045 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma

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2026-08-10: 0 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 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: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 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: 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: 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: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2026-01-02×clear all
type
  • 8k filing3,045
  • grant2,098
  • approval1,170
  • device adverse event1,000
  • device 510k885
  • device pma633
earnings
579
  • device recall415
  • recall220
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 29, 2025

    4
    ›Jan 2, 2026device 510k221d agoOrthocon, Inc. — MONTAGE XT Cranial Cement (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2026device 510k221d agoJamjoom Fullcare Corporation — Ready to use Nelaton Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2026device 510k221d agoNingbo Baichen Medical Devices Co., Ltd. — Mobility Scooter (BC-MS310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2026device 510k221d agoZuriMED Technologies AG — FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (510k cleared)

    Product code: OWX. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗

    Week of Jan 5, 2026

    46
    ›Jan 5, 2026device 510k218d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Total PSA II (tPSAII) (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k
    ← prev
    page 1 of 18
    next →
    218d ago
    Makrite Industries, Inc. — Disposable Medical Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k218d agoKaneka Americas Holding, Inc. — SurfRider 13 Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k218d agoRadformation, Inc. — ChartCheck (RADCH V1.6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k218d agoMaihub Corp. — maiLink (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k218d agoSamsung Medison Co., Ltd. — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k218d agoInnovacyn, Inc. — Puracyn® Plus Antimicrobial Irrigation Solution (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoAbanza Tecnomed S.L — QuadLock™ Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoHh Global Technology, Inc. — Pen Needle (510k cleared)GSI TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoMaterialise NV — Materialise TKA Guide System (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoVesalio, Inc. — V-DAC Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoEl Global Trade, Ltd. — Sensilift Pro (ST300XXYYZZZ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoCarlsmed, Inc. — aprevo® cervical interbody system (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoCrossroads Extremity Systems — TRILEAP Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoShanghai Medconn Medical Technology Co., Ltd. — Medconn 8K Glycated Hemoglobin Test System (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k217d agoInnaccel Technologies Private Limited — Saans (F4-01-00-000-000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoKerr Corporation — ZenSeal Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

    Product code: QAU. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

    Product code: PHN. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoDentsply Sirona, Inc. — DS Core Detect (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ Fortis (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoRemSleep Holdings, Inc. — DeltaWave Nasal Pillow System (510k cleared)RemSleep Holdings Inc.

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoAidoc Medical , Ltd. — BriefCase-Triage: CARE Multi-triage CT Body (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoMaterialise NV — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoBeame Medical Technology (Shenzhen) Limited — Clear Aligner (SCF-3348) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoInnovative Health — Reprocessed Agilis NxT Steerable Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoAvantec Vascular Corporation — Sangria™ Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoJJGC Indústria e Comércio de Materiais Dentários S.A. — Neodent InLab Validated Workflow (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoVy Spine, LLC — VyBrate™ VBR System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoS.M.A.I.O — KHEIRON® Spinal Fixation System, including patient specific K-ROD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoShenzhen Best Electronics Co., Ltd. — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k216d agoAmv Consulting, LLC — SmileInspector (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoZhongshan Xiaolan Town Senlan Electronic Factory — Fetal Doppler U8-25, U9-25 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoGE Healthcare — View (510k cleared)HCA Healthcare, Inc.

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoSpine Innovation, LLC — Titanium Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoIntelivation Technologies — Advantage-C™ Ti3D Cervical Interbody Fusion Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoSingular Health Pty, Ltd. — 3DICOM MD Cloud (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoIzenimplant Co., Ltd. — ZENEX Implant System_R-System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoTornier, Inc. — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (510k cleared)BioLight Israeli Life Sciences Ltd

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoShenzhen Med-Link Electronics Tech Co., Ltd. — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoImricor Medical Systems, Inc. — Vision-MR™ Diagnostic Catheter (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoKane Biotech, Inc. — revyve® Antimicrobial Skin and Wound Cleanser (510k cleared)IO Biotech, Inc.

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoMedtronic Minimed — MiniMed Go App (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 8, 2026device 510k215d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ Totus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 9, 2026device 510k214d agoAliveCor, Inc. — Corvair Monza (510k cleared)

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

    full page →fda device 510k ↗
    $RMSL
    $MMSI89.75+0.80%
    $HCA414.03+0.16%
    $MTLS6.5600-1.06%
    $GSIT
    $CARL
    $MTLS6.5600-1.06%
    $XRAY11.66-3.80%
    $IOBTQ