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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 0 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Aug 18, 2025

    25
    ›Aug 21, 2025device 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k346d 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 510k345d agoTherapixel — MammoScreen BD (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k345d 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 510k345d 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 510k345d agoDRGEM Corporation — PROMO (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 22, 2025device 510k345d 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 510k345d 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 510k345d 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 510k345d 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 510k345d 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 510k345d 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 510k345d 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 510k345d 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 510k345d 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

    25
    ›Aug 25, 2025device 510k342d 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 60 of 100
    next →
    342d ago
    Hemosonics, LLC — Quantra QStat Cartridge (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k342d 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 510k342d 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 510k342d 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 510k342d 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 510k342d agoNeuroears, Inc. — NeuroEars-Anna™ (510k cleared)NeurOp Inc

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

    full page →fda device 510k ↗
    ›Aug 25, 2025device 510k342d 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 510k342d 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 510k342d 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 510k341d agoIschemaview, Inc. — Rapid DeltaFuse (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k341d 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 510k341d agoBrainomix Limited — Brainomix 360 Triage Stroke (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k341d 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 510k341d agoImperative Care, Inc. — X-Wire Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 26, 2025device 510k341d 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 510k340d 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 510k340d 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 510k340d 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 510k340d 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 510k340d 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 510k340d agoOxehealth Limited — Vital Signs (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 27, 2025device 510k340d 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 510k340d 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 ↗
    ›Aug 27, 2025device 510k340d agoHangzhou Clongene Biotech Co., Ltd. — CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    $TMCI4.1900+4.49%
    $CAH229.12-1.46%
    $XRAY13.37-2.69%
    $AFJKU
    $XRAY13.37-2.69%
    $VECO59.42+2.95%