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calendar

408 catalysts · 3,295 8k filing · 1,080 grant · 1,000 device adverse event · 579 earnings · 519 approval · 408 device 510k

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 11 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 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: 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 catalysts
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type: device 510k×from 2026-03-04×clear all
type
  • 8k filing3,295
  • grant1,080
  • device adverse event1,000
  • earnings579
  • approval519
  • device 510k408
device pma
236
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area

    no tagged catalysts yet

    Week of Mar 2, 2026

    39
    ›Mar 4, 2026device 510k164d agoSpineCraft — ANTERIS Thoracolumbar Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoSatori Orthopaedics, Inc. — Active Intramedullary (AIM) Tibial Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoAevumed, Inc. — Aevumed FENIX Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoDevicor Medical Products, Inc. — Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoEscala Medical, Ltd. — Mendit (510k cleared)

    Product code: PBQ. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoLifevac, LLC — LifeVac (510k cleared)

    Product code: QXN. Advisory committee: Ear, Nose, Throat. Type: Direct

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoGlobalcare Medical Technology Co., Ltd. — TENS/EMS device (GUSE01) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoDentis Co., Ltd. — Dentis SQ-SL AXEL Fixture (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoDentsply Sirona, Inc. — SureSmile Software (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Electric Wheelchair (MP148) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoQT Imaging Holdings, Inc. — QT Scanner 2000 Model A (510k cleared)QT IMAGING HOLDINGS, INC.

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoRadcliffe Watts, LLC — Klär Lite (RCW-KL1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k164d agoOsstem Implant Co., Ltd. — Healing Abutment System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoZhuhai DR Medical Instruments Co., Ltd. — Extension tube (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoParagon 28, Inc. — Phantom® Hindfoot TTC/TC Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoNanosonics Limited — CORIS System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoEarlitec Diagnostics — EarliPoint Assessment (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoIvoclar Vivadent, Inc. — Adhese 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoArthrex, Inc. — Arthrex FibuLock Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoPhilips Medical Systems Nederland B.V. — AV Cardiac CT (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoOrca Dental AI , Ltd. — CEPHX3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k163d agoEsaote, S.p.A. — Magnifico Open (100009900) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoTreace Medical Concepts, Inc. — Treace Medical Concepts (TMC) Screw Fixation System (510k cleared)TREACE MEDICAL CONCEPTS, INC.

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoOlympus Medical Systems Corp. — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoTheramicro — TeKBrace Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoZhejiang Chuangxiang Medical Technology Co., Ltd. — Single use stone retrieval balloons (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoBunkerHill Health — Bunkerhill Contrast AVC (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoCalyxo, Inc. — CVAC Image Processor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoAdeor Medical AG — Velocity Alpha MR High Speed Surgical Drill System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoNano4imaging GmbH — EmeryGlide™ (EG18008901) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoFord Medtech, LLC — JFord Speculum Sleeve™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoHudens Bio Co., Ltd. — BONTREE PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoBunkerHill Health — Bunkerhill Contrast CAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoDepuy Ireland UC — VELYS™ Hip Navigation (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k162d agoGuangzhou Haoyimai Trading Co., Ltd. — Water-based lubricant (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 8, 2026device 510k160d agoOnera B.V. — Onera SleepMap (SLEEPMAP) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 9, 2026

    11
    ›Mar 9, 2026device 510k159d agoSynthes GmbH — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k
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    page 1 of 9
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    159d ago
    Fujifilm Corporation — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k159d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k159d agoWEBEST Biotech,, LLC — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k159d agoMedicell Healthcare Co.,LTD — Medicell Mycosis Laser (MCML24004) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k159d agoZimmer, Inc. — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k159d agoS&M Medical Co., Ltd. — NeoSculpt Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k159d agoQIAGEN GmbH — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k159d agoArthrex, Inc. — FiberTape Button (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k159d agoPerspectum, Ltd. — LiverMultiScan (v6.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k158d agoIvoclar Vivadent, Inc. — IPS e.max Zirconia (510k cleared)

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

    full page →fda device 510k ↗
    $QTIWW0.1500-18.92%
    $XRAY11.58+1.49%
    $TMCI4.1900+4.49%
    $UTMD69.19+0.06%
    $FOFO3.0000+2.39%