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659 catalysts · 3,045 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 579 earnings

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2026-08-10: 0 catalysts2026-08-11: 16 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: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2026-01-30×clear all
type
  • 8k filing3,045
  • grant2,029
  • device adverse event1,000
  • approval897
  • device 510k659
  • earnings579
device pma
503
  • device recall211
  • phase 2 completion172
  • recall167
  • therapy area

    no tagged catalysts yet

    Week of Jan 26, 2026

    12
    ›Jan 30, 2026device 510k193d agoHangzhou Clongene Biotech Co., Ltd. — Clungene RSV Antigen Rapid Test (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoShenzhen Peninsula Medical Group — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoSaeshin Precision Co., Ltd. — Motor Handpiece and Control Unit (SDI10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Disposable Distal End Tape Hood (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoParagonix Technologies, Inc. — BAROguard Donor Lung Preservation System (510k cleared)POET TECHNOLOGIES INC.

    Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoPrecision Medical Ventures, Inc. Dba Revealdx — RevealAI-Lung (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoShenzhen Jianchao Intelligent Technology Co., Ltd. — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoPrismatik Dentalcraft, Inc. — BruxZir® Shaded 16 PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoBoston Aesthetics, Inc. — Boston PICO (Boston PICO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoSorin Group Italia S.R.L. — Dual Stage Venous Cannulae (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2026device 510k193d agoAsistan Medikal — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2026device 510k192d agoMerit Medical Ireland, Ltd. — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 2, 2026

    38
    ›Feb 2, 2026device 510k190d agoNano-X Imaging , Ltd. — TAP2D (510k cleared)Nano-X Imaging Ltd.

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

    full page →fda device 510k ↗
    ›Feb 2, 2026device 510k
    ← prev
    page 1 of 14
    next →
    190d ago
    Chengdu Besmile Medical Technology Co., Ltd. — BIORES Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 2, 2026device 510k190d agoOxehealth Limited — Vital Signs (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 2, 2026device 510k190d agoBeijing Kreate Medical Co., Ltd. — Redermax Antibacterial Wound Matrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 2, 2026device 510k190d agoAsahi Intecc Co., Ltd. — CHIKAI Nexus petit (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoApplied Medical Technology, Inc. — Explant Express (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoDror Orthodesign , Ltd. — ZSmile System (510k cleared)Dror Ortho-Design, Inc.

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoStryker GmbH — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (510k cleared)STRYKER CORP

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoNingbo Runyes Medical Instrument Co., Ltd. — Diagnostic X-Ray Equipment Model POCT22 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoCircadia Health, Inc. — The Circadia C300 System (C300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoMedtronic Minimed — SmartGuard Technology; Predictive Low Glucose Technology (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoUlrich Medical USA, Inc. — Navigation Module of the Cortium® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoXi'An Taibo Electronic Technology Co., Ltd. — 808nm semiconductor laser hair removal machine (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoDexcom, Inc. — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (510k cleared)DEXCOM INC

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

    full page →fda device 510k ↗
    ›Feb 3, 2026device 510k189d agoMedacta International S.A. — MSS - Monobloc stem (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoOrthosoft Inc. (d/b/a) Zimmer CAS — Signature™ ONE System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoSpinal Elements, Inc. — Luna® Ti Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoBard Peripheral Vascular, Inc. — UltraScore™ Focused Force PTA Balloon (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoZimmer, Inc. — G7® Revision Acetabular System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoYadu Medical (Henan) Co., Ltd. — Henan Yadu Level 4 Surgical Gowns (Reinforced) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2026device 510k188d agoEvolution Spine — E3D™-C Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoEncora, Inc. — Encora X1 (510k cleared)Encore Inc.

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoDentsply Sirona — Primevision 3D (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoGe Medical Systems, LLC — SIGNA™ Sprint Select (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoPenumbra, Inc. — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Feb 5, 2026device 510k187d agoArgon Medical Devices, Inc. — CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoAthelas, Inc. — Athelas Home (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoK2m, Inc. — Q Interbody Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoQuantel Medical — INTEGRE LIO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoEieling Technology (Shenzhen) Limited — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoGe Medical Systems, LLC — SIGNA™ Bolt (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoSiemens Healthcare Diagnostics, Inc. — Atellica® IM TSH3-Ultra II (TSH3ULII) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoStryker Leibinger GmbH & Co KG — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoUzinmedicare Co., Ltd. — Spectra S1 Pro; Spectra S2 Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoLive Medica, LLC — LiveMedica Enterprise PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoFujifilm Corporation — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (510k cleared)Fujifilm Holdings Corp

    Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoSafeBeat Rx, Inc. — SafeBeat Rx App (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 6, 2026device 510k186d agoMedian Technologies — Median LCS (internal name) / eyonis LCS (trade name) (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    $NNOX1.7300+1.17%
    $POET6.7800+2.73%
    $ECR
    $XRAY11.66-3.80%
    $PEN324.29-0.11%
    $SYK345.81+2.00%
    $DXCM87.65+3.42%
    $DROR0.00500.00%