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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 0 catalysts2026-08-06: 0 catalysts2026-08-07: 34 catalysts2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 11 catalysts2026-08-11: 10 catalysts2026-08-12: 13 catalysts2026-08-13: 12 catalysts2026-08-14: 3 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 1 catalyst2026-08-20: 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: 10 catalysts2026-10-29: 17 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,811
  • device 510k5,000
  • grant4,728
  • 8k filing2,984
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings512
  • therapy area

    no tagged catalysts yet

    Week of Mar 2, 2026

    31
    ›Mar 4, 2026device 510k157d 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 510k157d 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 510k157d 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 510k157d 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 510k157d 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 510k157d 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 510k156d 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 510k156d 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 510k156d agoNanosonics Limited — CORIS System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k156d agoEarlitec Diagnostics — EarliPoint Assessment (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k156d agoIvoclar Vivadent, Inc. — Adhese 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k156d agoArthrex, Inc. — Arthrex FibuLock Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k156d 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 510k156d agoOrca Dental AI , Ltd. — CEPHX3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 5, 2026device 510k156d 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 510k156d 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 510k155d 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 510k155d 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 510k155d agoTheramicro — TeKBrace Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k155d 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 510k155d 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 510k155d agoBunkerHill Health — Bunkerhill Contrast AVC (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k155d agoCalyxo, Inc. — CVAC Image Processor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k155d 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 510k155d agoNano4imaging GmbH — EmeryGlide™ (EG18008901) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k155d 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 510k155d agoHudens Bio Co., Ltd. — BONTREE PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k155d agoBunkerHill Health — Bunkerhill Contrast CAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k155d agoDepuy Ireland UC — VELYS™ Hip Navigation (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2026device 510k155d 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 510k153d 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

    19
    ›Mar 9, 2026device 510k152d 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
    ← prev
    page 93 of 100
    next →
    152d 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 510k152d 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 510k152d 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 510k152d 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 510k152d 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 510k152d 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 510k152d 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 510k152d agoArthrex, Inc. — FiberTape Button (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 9, 2026device 510k152d agoPerspectum, Ltd. — LiverMultiScan (v6.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoIvoclar Vivadent, Inc. — IPS e.max Zirconia (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoAzena Medical, LLC — Gemini NOVA 810+980 Soft Tissue Laser (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoSynthes GmbH — DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoFUJIFILM Sonosite, Inc. — Sonosite iLOOK Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoInstitut Straumann AG — Straumann® BLC Implants - Indication Widening (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoReselute, Inc. — Reselute Tibial Nail (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoCefla S.C. — myray ProXIma X6 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoCanon Medical Systems Corporation — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2026device 510k151d agoNakanishi, Inc. — Varios Combi Pro2 (510k cleared)

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

    full page →fda device 510k ↗
    $QTIWW0.1500-18.92%
    $XRAY12.12-7.97%
    $TMCI4.1900+4.49%
    $FOFO3.0000+2.39%