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5,000 catalysts · 18,987 approval · 5,627 phase readout · 5,000 device 510k · 4,728 grant · 2,759 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 47 catalysts2026-08-06: 13 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 2 catalysts2026-08-13: 2 catalysts2026-08-14: 1 catalyst2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 2 catalysts2026-08-19: 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: 1 catalyst2026-09-24: 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: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 0 catalysts2026-10-27: 3 catalysts2026-10-28: 2 catalysts2026-10-29: 8 catalysts2026-10-30: 3 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,627
  • device 510k5,000
  • grant4,728
  • 8k filing2,759
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings344
  • therapy area

    no tagged catalysts yet

    Week of Jan 12, 2026

    9
    ›Jan 16, 2026device 510k202d agoZimmer Medizinsysteme GmbH — CoolTone (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d agoSublimed — actiTENS mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2026device 510k202d 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 510k202d 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 510k202d agoOpsens, Inc. — OptoMonitor 3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2026device 510k201d 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 510k201d 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 510k200d 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 510k200d 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

    41
    ›Jan 20, 2026device 510k198d 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
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    page 86 of 100
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    198d 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 510k198d 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 510k198d agoBlue Ocean Global — Excelsior System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 20, 2026device 510k198d 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 510k198d 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 510k198d 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 510k198d 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 510k198d 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 510k197d 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 510k197d 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 510k197d 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 510k197d 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 510k197d 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 510k197d 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 510k197d 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 510k197d 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 510k197d 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 510k196d 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 510k196d 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 510k196d 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 510k196d 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 510k196d agoGeistlich Pharma AG — Device 104 Particulate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k196d 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 510k196d 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 510k196d 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 510k196d 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 510k196d 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 510k196d agoCopan Wasp Srl — PhenoMATRIX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k196d 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 510k195d 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 510k195d 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 510k195d 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 510k195d 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 510k195d 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 510k195d 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 510k195d 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 510k195d 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 510k195d 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 510k195d 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 510k195d 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 ↗
    $MDCE0.00020.00%
    $AXIM
    $ABBV243.80-0.53%
    $VYCO0.06600.00%
    $MMSI85.82+0.34%
    $MDT86.20-0.55%
    $UTMD69.19+0.06%
    $FRTRY
    $SLGN
    $MDCE0.00020.00%
    $BSX49.09+1.36%