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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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2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 11 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 catalysts2026-10-26: 0 catalysts2026-10-27: 2 catalysts2026-10-28: 1 catalyst2026-10-29: 3 catalysts2026-10-30: 0 catalysts2026-10-31: 0 catalysts2026-11-01: 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 Oct 27, 2025

    50
    ›Oct 27, 2025device 510k280d agoTechfit Digital Surgery, Inc. — TECHFIT Patient-Specific Cranial System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k280d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (HL-3058, F5112) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k280d agoViet Phu Trade and Import Export Co., Ltd. — Disposable Vinyl Examination Gloves (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k280d agoAffinity Biosensors, LLC — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 27, 2025device 510k280d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (HL-3060, F5113) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoVolcano Corporation (Dba Philips Image Guided Therapy Device — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoCg Medtech Co., Ltd. — UniSpace® TPLIF Cage (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoBaylis Medical Technologies, Inc. — PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoBoston Scientific Corporation — TheraSphere 360™ Y-90 Management Platform (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoWellell, Inc. — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoBodycad Laboratories, Inc. — Fine Osteotomy™ (510k cleared)Barr Laboratories Inc

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoTyber Medical, LLC — Navigated Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoShofu Dental Corporation — ZIRCONOMER P (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 28, 2025device 510k279d agoNeocis, Inc. — Yomi S Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ E10 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoHuxley Medical — SANSA HSAT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoWright Medical Technology, Inc. (Stryker Corporation) — Synchfix EVT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ E10s (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoInari Medical — Protrieve Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoMedtronic, Ireland — Telescope Guide Extension Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoSmith & Nephew, Inc. — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoOd-Os GmbH — Navilas Laser System 577sl (156691) (510k cleared)

    Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoFissiontech, LLC — Difiney Advanced Anti Snoring Device 4.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoABBOTT MEDICAL — Seguin Annuloplasty Ring (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitor (C1216W, C822W, C821W) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoArthrex, Inc. — Arthrex SutureTak Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoMaxx Orthopedics, Inc. — Freedom Infinia™ Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoOrtho-Clinical Diagnostics, Inc. — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoSu-Ko Technologies, LLC — SER Pen Carain MicroSystem (MP1209SP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoGuangdong Optomedic Technologies, Inc. — 3D Laparoscope (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoFH Industrie — JARVIS Diaphyseal Stem Standard (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoMeduloc, LLC — Meduloc Intramedullary Fracture Fixation (IFF) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 29, 2025device 510k278d agoYa-Man, Ltd. — Medi Lift Essential Eye Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoTornier, Inc. — Tornier Humeral Reconstruction System Max (Tornier HRS Max) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoDetax GmbH — Freeprint® denture flex (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoImperative Care, Inc. — Zoom System (Zoom 4S Catheter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoCarefusion (Bd) — BD Alaris Pump Infusion Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoArctx Medical — Arctx Cool Catheter Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Urinary Tract Infection Test (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoDiasorin Molecular, LLC — Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoTaewoong Medical Co., Ltd. — Niti-S Esophageal Stent; Esophageal TTS Stent (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoMerchsource, LLC — AIR COMPRESSION BOOTS 1018195,1018196 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoBoston Scientific Corporation — OBSIDIO™ Conformable Embolic (M0013972101010) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoParagon Implant Mfg., LLC — GEN5 and GEN5+ Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoCytrellis Biosystems, Inc. — ellacor System with Micro-Coring Technology (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoViTAA Medical Solutions, Inc. — AiORTA - Plan (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoM.I.Tech Co., Ltd. — HANAROSTENT Esophagus Upper (CCC) (510k cleared)YSX Tech Co., Ltd

    Product code: ESW. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Oct 30, 2025device 510k277d agoBoston Scientific Corporation — Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ← prev
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    $BSX46.73+1.59%
    $YSXT
    $BSX46.73+1.59%
    $FOFO3.0000+2.39%
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    $SNN30.25+5.29%
    $MDCE0.00020.00%