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741 catalysts · 3,288 8k filing · 2,051 grant · 1,024 approval · 1,000 device adverse event · 741 device 510k · 584 earnings

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type: device 510k×from 2026-01-19×clear all
type
  • 8k filing3,288
  • grant2,051
  • approval1,024
  • device adverse event1,000
  • device 510k741
  • earnings584
device pma
543
  • device recall277
  • recall204
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 19, 2026

    45
    ›Jan 20, 2026device 510k206d agoCooper Surgical — Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k206d agoMedtronic, Inc. — Clearview Intracoronary Shunts (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k206d agoScivita Medical Technology Co., Ltd. — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k206d agoBlue Ocean Global — Excelsior System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k206d agoCanon Medical Systems Corporation — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k206d agoTeleflex Medical Sdn. Bhd. — Rusch SoftSimplastic Foley Catheters (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k206d agoShanghai United Imaging Healthcare Co., Ltd. — uCT 780 with uWS-CT-Dual Energy Analysis (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k206d agoCarestream Health — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k206d agoArgon Medical Devices, Inc. — VariFuse Adjustable Infusion Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 21, 2026device 510k205d 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 510k205d 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 510k205d 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 510k205d 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 510k205d 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 510k205d 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 510k205d 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 510k205d 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 510k205d 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 510k204d 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 510k204d 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 510k204d 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 510k204d 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 510k204d agoGeistlich Pharma AG — Device 104 Particulate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d 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 510k204d 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 510k204d 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 510k204d 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 510k204d 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 510k204d agoCopan Wasp Srl — PhenoMATRIX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d 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 510k203d agoElidah, Inc. — Elitone for Men (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 24, 2026device 510k202d 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 510k202d 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

    5
    ›Jan 26, 2026device 510k200d 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
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    200d 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 510k200d 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 510k199d 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 510k199d 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 ↗
    $SLGN
    $MDCE0.00020.00%
    $FRTRY
    $OM4.5200-1.09%
    $MDT90.58-0.20%
    $BSX51.69+0.53%
    $UTMD69.19+0.06%
    $MMSI90.50-0.77%
    $VYCO0.06600.00%