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430 catalysts · 3,288 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 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: 4 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 2026-03-02×clear all
type
  • 8k filing3,288
  • grant1,096
  • device adverse event1,000
  • earnings580
  • approval550
  • device 510k430
device pma
248
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area

    no tagged catalysts yet

    Week of Mar 2, 2026

    50
    ›Mar 2, 2026device 510k165d agoNanjing Dewen Medical Technology Co., Ltd. — Microwave Ablation Device (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoKarl Storz SE & CO. KG — KARL STORZ Mediastinoscopes and Instruments (510k cleared)

    Product code: EWY. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoNanjing Devin Medical Technology Co., Ltd. — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoClarius Mobile Health Corp. — Clarius Ejection Fraction AI (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoMyofunctional Research Co. — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoGyrus Acmi, Inc. — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoLiaoning Upcera Co., Ltd. — “FLNT Base” and “FLNT Temp” (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoGuangzhou Heygears IMC., Inc. — UltraPrint-Dental Hard Splint UV (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoArthrex, Inc. — Arthrex Nano FiberTak Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoSynthes GmbH — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 2, 2026device 510k165d agoMesi D.O.O. — MESI mTABLET SPIRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoZhejiang Hangkang Medical Equipment Co., Ltd. — Surgical Face Mask (Ear mount) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoL&K BIOMED Co., Ltd. — PathLoc Lumbar Plate System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoRam.Shaw Pte. , Ltd. — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoHarrison-AI Medical Pty, Ltd. — Annalise Enterprise (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoTHINK Surgical, Inc. — TMINI® Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoSota Cloud Corp. — SOTA Cloud Smart Sensor (1.5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoHaidari Beauty Technology (Beijing) Co., Ltd. — CO2 Laser Treatment Machine (CFR3M1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoArthrex, Inc. — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoNew Stetic, SA — ZAFIRA® (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoShenzhen Hanhua Opto Co., Ltd. — LED Therapy Light (COB1400, HP1800PRO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 3, 2026device 510k164d agoPremier Dental Products Company — Bond-PR™ Universal Adhesive (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k163d agoSpineCraft — ANTERIS Thoracolumbar Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k163d 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 510k163d 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 510k163d agoAevumed, Inc. — Aevumed FENIX Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k163d 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 510k163d agoEscala Medical, Ltd. — Mendit (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k163d agoLifevac, LLC — LifeVac (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 4, 2026device 510k163d 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 510k163d 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 510k163d 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 510k163d 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 510k163d 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 510k163d 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 510k163d 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 510k162d 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 510k162d 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 510k162d agoNanosonics Limited — CORIS System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k162d agoEarlitec Diagnostics — EarliPoint Assessment (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k162d agoIvoclar Vivadent, Inc. — Adhese 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k162d agoArthrex, Inc. — Arthrex FibuLock Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k162d 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 510k162d agoOrca Dental AI , Ltd. — CEPHX3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k162d 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 510k162d 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 510k161d 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 510k161d 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 510k161d agoTheramicro — TeKBrace Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k161d 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 ↗
    ← prev
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    $QTIWW0.1500-18.92%
    $TMCI4.1900+4.49%
    $UTMD69.19+0.06%
    $XRAY11.58+1.49%