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2,051 catalysts · 4,728 grant · 3,086 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma

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2026-08-10: 0 catalysts2026-08-11: 57 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: 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 2025-08-21×clear all
type
  • grant4,728
  • 8k filing3,086
  • approval2,606
  • device 510k2,051
  • device recall1,649
  • device pma1,418
device adverse event
1,000
  • earnings583
  • recall551
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Aug 18, 2025

    26
    ›Aug 21, 2025device 510k356d agobioMerieux, Inc. — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (510k cleared)BIOMERICA INC

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoBodycad Laboratories, Inc. — Fine Osteotomy™ (510k cleared)Barr Laboratories Inc

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoVista AI, Inc. — Vista OS, Vista AI Scan, RTHawk (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoFinemedix Co., Ltd. — ClearTip FNA and FNB Types (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoAcumed, LLC — The Acumed Wrist Fixation System - 2.4mm Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoTreace Medical Concepts — Treace Medical Concepts (TMC) Implant Fixation System (510k cleared)TREACE MEDICAL CONCEPTS, INC.

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoShenzhen Fittop Health Technology Co., Ltd. — LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoDentsply Sirona, Inc. — MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoShenzhen Yicai Health Technology Co., Ltd. — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) (510k cleared)Aimei Health Technology Co., Ltd.

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoJiangsu Jumao X-Care Medical Equipment Co., Ltd. — Portable Oxygen Concentrator (JM-P50A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoEver Global (Vietnam) Enterprise Corporation — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid (510k cleared)Teva Pharmaceuticals USA Inc

    Product code: LZA. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoNerv Technology Inc. (D.B.A.) Fluidai Medical — Origin™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 21, 2025device 510k356d agoTidal Medical Technologies, LLC — InSee (510k cleared)Samson Medical Technologies LLC

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoTherapixel — MammoScreen BD (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoCardinalhealth — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoCenterpoint Systems — CPS Locator 3D Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoDRGEM Corporation — PROMO (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoAdvanced Technology Research (A.T.R.) S.R.L. — EnDrive (EnDriveUS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoUnited Orthopedic Corporation — Stem Extension Line (USTAR II System) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoCerenovus, Inc. — CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoBiosense Webster, Inc. — CARTO™ 3 EP Navigation System V8.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoReflow Medical, Inc. — CoraForce Microcatheter, CoraFlex Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoMediclus Co., Ltd. — One-Fil Putty Injectable (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoAccess Bio, Inc. — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k355d agoGalileo Cds, Inc. — GBrain MRI (510k cleared)

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

    full page →fda device 510k ↗

    Week of Aug 25, 2025

    24
    ›Aug 25, 2025device 510k352d agoDermalogica, LLC — PRO Pen Microneedling System (6883) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k
    ← prev
    page 1 of 42
    next →
    352d ago
    Hemosonics, LLC — Quantra QStat Cartridge (510k cleared)

    Product code: QFR. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k352d agoOlea Medical S.A.S. — Neurovascular Insight V1.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k352d agoSpark Biomedical, Inc. — Sparrow Ascent (510k cleared)RNR BioMedical Inc

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k352d agoNobel Biocare AB — NobelZygoma TiUltra Implant system (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k352d agoDenmat Holding, LLC — DenMat Multilayered Zirconia Disc (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k352d agoNeuroears, Inc. — NeuroEars-Anna™ (510k cleared)NeurOp Inc

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k352d agoDentsply Sirona, Inc. — Motor and Apex Module (MaAM) (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k352d agoPrecision Biologic, Inc. — CRYOcheck Chromogenic Factor VIII (510k cleared)

    Product code: GGP. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k352d agoMaxx Orthopedics, Inc. — Maxx Libertas Bipolar Hip Head (Bipolar Hip) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k351d agoIschemaview, Inc. — Rapid DeltaFuse (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k351d agoSeplou (Zhuhai) Co., Ltd. — Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k351d agoBrainomix Limited — Brainomix 360 Triage Stroke (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k351d agoHeager GmbH — Heager Medical Laser Family (Sabrina/Adolf) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k351d agoImperative Care, Inc. — X-Wire Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k351d agoKitazato Corporation — Ultra-Fast Vitri; Ultra-Fast Warm (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k350d agoAidite (Qinhuangdao) Technology Co., Ltd. — Additively Manufactured Aligner Resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k350d agoDurr Dental SE — VistaSoft 4.0 and VisionX 4.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k350d agoLesspine Innovations — ELID (Endoscopic Less Invasive Decompression) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k350d agoNanjing Yinuoji Medical Technology Co., Ltd. — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k350d agoUv One Hygienics, Inc. — KnoxFog Anti-fogging Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k350d agoOxehealth Limited — Vital Signs (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k350d agoShanghai AnQing Medical Instrument Co., Ltd. — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k350d agoEdan Instruments, Inc. — Fetal & Maternal Monitor (F15A, F15A Air) (510k cleared)VEECO INSTRUMENTS INC

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

    full page →fda device 510k ↗
    $BMRA
    $XRAY11.66-3.80%
    $AFJKU
    $TMCI4.1900+4.49%
    $CAH237.49+0.13%
    $XRAY11.66-3.80%
    $VECO59.42+2.95%