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732 catalysts · 3,045 8k filing · 2,046 grant · 1,007 approval · 1,000 device adverse event · 732 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 2026-01-21×clear all
type
  • 8k filing3,045
  • grant2,046
  • approval1,007
  • device adverse event1,000
  • device 510k732
  • earnings579
device pma
539
  • device recall255
  • recall204
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 19, 2026

    36
    ›Jan 21, 2026device 510k202d agoVerge Medical, Inc. — RoVo Mechanical Thrombectomy System (510k cleared)VYCOR MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k202d agoNova Biomedical Corporation — Nova Max Creat eGFR Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k202d agoArthrex, Inc. — Arthrex Variable Angle (VA) Proximal Tibia Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k202d agoBoston Aesthetics, Inc. — Boston Pico755 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k202d agoDigital Surgery Systems, Inc. (D.B.A True Digital Surgery) — Affirm 400 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k202d agoMerit Medical Ireland, Ltd. — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k202d agoVarian Medical Systems, Inc. — Halcyon, Ethos Radiotherapy System (5.0) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k202d agoMedtronic Sofamor Danek USA, Inc. — Infinity™ OCT System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k202d agoHangzhou SHINING3D Dental Technology Co., Ltd. — LumiCera (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoImplant Protesis Dental 2004, S.L. — IPDmilled Blanks (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoLima Corporate S.P.A. — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoMaquet GmbH (A Getinge Group Company) — Getinge GSS67N Series Steam Sterilizer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoCultiv8 1, LLC — Genie MAX Large Bore Introducer Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoGeistlich Pharma AG — Device 104 Particulate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoMedela, LLC — Pump In Style® Pro+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoAstura Medical — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoPerin Health Devices, LLC — Perin Health System (PHD80060-2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoSiemens Healthcare GmbH — AI-Rad Companion Brain MR (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoPhilips Medical Systems Nederland B.V. — AV Vascular (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoCopan Wasp Srl — PhenoMATRIX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k201d agoInstitut Straumann AG — Straumann Variobase Abutments XC for Bridge/Bar (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoAb Medica Sas — Pneumo Dissector Hook (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoRandox Laboratories Limited — Evidence MultiSTAT DOA Urine MultiPlex (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoPoint Robotics MedTech, Inc. — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoDevicor Medical Products, Inc. — HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoBoston Scientific Cardiac Diagnostic Technologies, Inc. — BodyGuardian Remote Monitoring System (BGRMS v3.0) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoBasic Medical Technology, Inc. — Syntex Exam Gloves (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoManteia Technologies Co., Ltd. — AccuContour 4.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoSilk Holdings, Inc. — New Day Skin Spray (510k cleared)SILGAN HOLDINGS INC

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoLife Spine, Inc. — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoShenzhen Rainbow Technology Co., Ltd. — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoGe Healthcare Coils (Usa Instruments, Inc.) — 3.0T AIR 32CH HNA (510k cleared)

    Product code: MOS. Advisory committee: Radiology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k200d agoElidah, Inc. — Elitone for Men (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2026device 510k199d agoVydence Medical Industria E Commercio Ltda — Vydence Family of Lasers (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2026device 510k199d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Holmium Laser Therapeutic Apparatus (HZ-40) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jan 26, 2026

    14
    ›Jan 26, 2026device 510k197d agoOutset Medical, Inc. — Tablo Hemodialysis System (PN-0008000, PN-0006000U) (510k cleared)Outset Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jan 26, 2026device 510k
    ← prev
    page 1 of 15
    next →
    197d ago
    Eyas Medical Imaging, Inc. — Ascent3T Neonatal Magnetic Resonance Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 26, 2026device 510k197d agoGe Medical Systems Information Technologies, Inc. — MAC 7 Resting ECG Analysis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k196d agoSoniquence, LLC — Reusable 3 Button Fingerswitch Wand (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k196d agoBalt USA, LLC — Optima Coil System (OptiOne Coil System) (510k cleared)Bayer USA LLC

    Product code: HCG. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k196d agoInbella Medical, Inc. — InbellaIgnite RF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k196d agoBeckman Coulter, Inc. — Access anti-HAV IgM (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 27, 2026device 510k196d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k195d agoEver Fortune.Ai, Co., Ltd. — Seg Pro V3 (RT-300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k195d agoNingbo Zhenhai Yihao Electronic Technology Co., Ltd. — Hand Massager (SM004D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k195d agoSterivic Medical Co., Ltd. — Sterilization Pouch/Roll (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k195d agoSleepiz AG — Sleepiz One+ (Model 2.5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k195d agoKoru Medical Systems, Inc. — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (510k cleared)KORU Medical Systems, Inc.

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

    full page →fda device 510k ↗
    ›Jan 28, 2026device 510k195d agoImricor Medical Systems — NorthStar™ Mapping System (510k cleared)

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

    full page →fda device 510k ↗
    $VYCO0.06600.00%
    $SLGN
    $FRTRY
    $MMSI89.75+0.80%
    $UTMD69.19+0.06%
    $BSX50.46+2.33%
    $MDCE0.00020.00%
    $OM4.5200-1.09%
    $KRMD4.0650+2.65%