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770 catalysts · 3,288 8k filing · 2,062 grant · 1,054 approval · 1,000 device adverse event · 770 device 510k · 584 earnings

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type: device 510k×from 2026-01-16×clear all
type
  • 8k filing3,288
  • grant2,062
  • approval1,054
  • device adverse event1,000
  • device 510k770
  • earnings584
device pma
553
  • device recall284
  • recall204
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 12, 2026

    29
    ›Jan 16, 2026device 510k210d agoSolius Labs, Inc. — SOLIUS PRO UVB Light Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoCepheid — Xpert GI Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoSana Health — Sana Device (510k cleared)

    Product code: QYN. Advisory committee: Physical Medicine. Type: Direct

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoQure.Ai Technologies — qXR-Detect (510k cleared)BMP AI Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoToro Neurovascular, Inc. — Toro 88 Superbore Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoMedtronic — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoMY01, Inc. — MY01 Continuous Compartmental Pressure Monitor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoPhelcom Technologies — Eyer 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoVital Healthcare Sdn. Bhd. — VITAL Tubing Sets for Hemodialysis (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoCuriteva, Inc. — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoFlexicare Medical Limited. — FL-10000U Respiratory Humidifier (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoLin-Zhi International, Inc. — LZI Buprenorphine II Enzyme Immunoassay (510k cleared)LIQTECH INTERNATIONAL INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoSpirair, Inc. — SeptAlign (510k cleared)SPIRE INC

    Product code: NHB. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoPhilips Medical Systems B.V. — Azurion R3.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoSoftlink International Private Limited — Imagine® Enterprise Suite (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoHycor Biomedical — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg (510k cleared)Dawn Sea Therapeutics

    Product code: DHB. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoIntuitive Surgical, Inc. — da Vinci Surgical System (IS5000) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoSurGenTec, LLC — Ion-C (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoTruvian Sciences, Inc. — Tru Hematology Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoZimmer Medizinsysteme GmbH — CoolTone (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoSublimed — actiTENS mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoBaxter Healthcare Corp/ Excel Medical — WAVE Clinical Platform (2.0.000) (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoAbbVie — Natrelle 133S Tissue Expanders (510k cleared)AbbVie Inc.

    Product code: LCJ. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k210d agoOpsens, Inc. — OptoMonitor 3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2026device 510k209d agoMedtronic, Ireland — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2026device 510k209d agoAuxilium Biotechnologies, Inc. — NeuroSpan Bridge (510k cleared)AXIM BIOTECHNOLOGIES, INC.

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

    full page →fda device 510k ↗
    ›Jan 18, 2026device 510k208d agoBiosense Webster, Inc. — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 18, 2026device 510k208d agoBaylis Medical Technologies, Inc. — Baylis Connector Cable (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗

    Week of Jan 19, 2026

    21
    ›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 510k
    ← prev
    page 1 of 16
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    206d ago
    Medtronic, 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 ↗
    $MDCE0.00020.00%
    $AXIM
    $ABBV250.82+0.83%
    $ISRG401.270.00%
    $ISRG401.270.00%
    $LIQT
    $BMPA
    $MDT90.58-0.20%
    $SRJN
    $MDT90.58-0.20%
    $VYCO0.06600.00%
    $MMSI90.50-0.77%