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calendar

5,000 catalysts · 18,987 approval · 5,159 phase readout · 5,000 device 510k · 4,728 grant · 2,516 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 60 catalysts2026-07-30: 13 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 0 catalysts2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,159
  • device 510k5,000
  • grant4,728
  • 8k filing2,516
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa319
  • therapy area

    no tagged catalysts yet

    Week of May 26, 2025

    15
    ›May 30, 2025device 510k426d agoFertipro NV — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — KALA Red Light Face Mask (KALA-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Endoscopic Distal Attachment (AF-D series) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoClairity, Inc. — Allix5 (510k cleared)

    Product code: SEZ. Advisory committee: Radiology. Type: Direct

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoSpident Co., Ltd. — EsFlow PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoMaquet Cardiovascular, LLC — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoTheramicro — TekBrace Solo Soft Tissue Reinforcement Device (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoBalt USA, LLC — Prestige Coil System (Prestige Packing Line Extension) (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoAudax D.O.O. — AudaxCeph Cephalogram Analysis Software (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoVapocoolshot, Inc. — DentalJect (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoHyperfine, Inc. — Swoop® Portable MR Imaging® System (V2) (510k cleared)Hyperfine, Inc.

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoTalladium España, SL — Dynamic TiBase (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoOlympus Medical Systems Corporation — Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoRoche Molecular Systems, Inc. — Opulus™ Lymphoma Precision (510k cleared)

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

    full page →fda device 510k ↗
    ›May 31, 2025device 510k425d agoLimFlow, Inc. — LimFlow ARC (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 2, 2025

    35
    ›Jun 2, 2025device 510k423d 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 510k
    ← prev
    page 45 of 100
    next →
    423d ago
    W. 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 510k423d 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 510k423d 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 510k423d 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 510k422d 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 510k422d 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 510k422d 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 510k422d 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 510k422d agoPhasor Health, LLC — EVAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k422d 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 510k422d 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 510k422d 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 510k422d agoClemde SA DE CV — Partial Flex (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 3, 2025device 510k422d 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 510k422d 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 510k422d 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 510k421d 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 510k421d 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 510k421d 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 510k421d agoPhyscade, Inc. — PhysCade System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k421d 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 510k421d 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 510k421d 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 510k421d 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 510k421d 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 510k421d 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 510k421d agoSk Zen, LLC — LubriZenzs (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k421d agoBrainlab , Ltd. — TraumaCad Neo (1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k421d agoProprio, Inc. — Paradigm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 4, 2025device 510k421d 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 510k421d 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 510k421d 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 510k420d 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 510k420d agoPhilips DS North America, LLC — UroNav 4 (510k cleared)

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

    full page →fda device 510k ↗
    $HYPR
    $NTRB2.9000-11.59%