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calendar

2,785 catalysts · 4,728 grant · 3,045 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma

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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: 20 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 2025-06-02×clear all
type
  • grant4,728
  • 8k filing3,045
  • device 510k2,785
  • approval2,724
  • device recall2,000
  • device pma1,962
device adverse event
1,000
  • recall693
  • earnings578
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 2, 2025

    50
    ›Jun 2, 2025device 510k435d agoScience & Bio Materials (S.B.M.) Sas — PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 2, 2025device 510k435d agoW. L. Gore & Associates, Inc. — GORE® Tri-Lobe Balloon Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 2, 2025device 510k435d agoAcuity Surgical Devices, LLC — Tera Lumbar Interbody Fusion System (Various PNs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 2, 2025device 510k435d agoSysmex America, Inc. — Automated Blood Coagulation Analyzer CN-Series (CN-6000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 2, 2025device 510k435d agoMacroLux Medical Technology Co., Ltd. — CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoRz Medizintechnik GmbH — RZ Resectoscope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoGlove One, LLC — GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (510k cleared)NutriBand Inc.

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoKardium, Inc. — Globe Introducer (601-01001) (510k cleared)Kardigan Inc

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoCintron Medical Corporation — gi2000 Electrosurgical Generator (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoPhasor Health, LLC — EVAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoSpinal Simplicity, LLC — Patriot SI Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoPentax of America, Inc. — PENTAX Medical Video Processor (EPK-i8020c) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoBalt USA, LLC — Raptor Aspiration Catheter; Balt Aspiration Tubing Set (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoClemde SA DE CV — Partial Flex (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoAroa Biosurgery , Ltd. — Endoform Reconstructive Template - PLGA (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k434d agoSerim Research — DISINTEK™ PA Test Strips (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoPhilips Medical Systems Nederland B.V. — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoId Korea Co., Ltd. — ID LIGHT CURE SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoOlympus Medical Systems Corporation — Disposable Balloon Catheter B5-2C (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoPhyscade, Inc. — PhysCade System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoMedifield Medical Co., Ltd. — Montblanc Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoNg Biotech — NG-Test® CTX-M MULTI (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoJkh Health Co., Ltd. — Ultrasound Stimulator (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoWeero Co., Ltd. — EVE Synergy (EVE-20M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoSurgify Medical OY — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoBarbaras Development, Inc. — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoSk Zen, LLC — LubriZenzs (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoBrainlab , Ltd. — TraumaCad Neo (1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoProprio, Inc. — Paradigm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoThe ScottCare Corporation — TeleRehab Aermos Cardiopulmonary Rehabilitation (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoPromisemed Hangzhou Meditech Co., Ltd. — Blood collection tube holders (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k433d agoKerecis Limited — Tendon Protect (50242) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — Portable Oxygen Concentrator (Spirit-3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoPhilips DS North America, LLC — UroNav 4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoGrumpy Innovation, Inc. — Portare System (FA-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoEstetic Ceram AG — zirkon; structure; LFU shades, stains and glazes (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoCorin U.S.A. Limited — Trinity EVO Acetabular Shell (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoNihon Kohden Digital Health Solutions, LLC — Central Station (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoIcu Medical, Inc. — Clave™ Neutral-Displacement Needlefree Connectors (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoOlympus Medical Systems Corp. — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoShenzhen Idea Light Limited — Red Light Hair Growth Cap (LP-RJVGRW-BLK) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoDeepHealth, Inc. — TechLive (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoGe Medical Systems, LLC — Sonic DL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoSynapse Biomedical, Inc. — Synchrony (20-3000) (510k cleared)RNR BioMedical Inc

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoMedtronic Navigation, Inc. — Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 5, 2025device 510k432d agoBrightheart — BrightHeart View Classifier (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoGlobus Medical, Inc. — ONVOY™ Acetabular System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoHebei JT Medical Co., Ltd. — Nd: YAG Laser Therapy System (QN-1) (510k cleared)

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

    full page →fda device 510k ↗
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    $GMED79.93+1.27%
    $ICUI182.42-1.16%
    $NTRB2.9000-11.59%