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calendar

5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 0 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 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: 1 catalyst2026-10-22: 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 readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Oct 13, 2025

    25
    ›Oct 16, 2025device 510k291d agoRiverpoint Medical — ProZip Knotless Implant (510k cleared)

    Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k291d agoSc Medica — FFX Facet Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k291d agoMatelaser, Inc. — MateLaser Medical Diode Laser Systems (ML-DLS-30) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k291d agoAsterasys Co., Ltd. — Coolfase (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 16, 2025device 510k291d agoMaxigen Biotech, Inc. — SurgiAid Collagen Wound Dressing (HA) (510k cleared)NKGen Biotech Inc

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoX9, Inc. — X9 Ultrasound System (510k cleared)XP Inc.

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoSpectrawave, Inc. — X1-FFR (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoPhilips Medizin Systeme Boeblingen GmbH — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoMedtronic Navigation, Inc. — StealthStation S8 Spine Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoSureax Medical, LLC — SureAx-Guide™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoOlympus Medical Systems Corp. — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoEndosound, Inc. — Biopsy Port Adapter (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoCitieffe S.R.L. — Estremo Fibular Nail (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoSiemens Healthcare Diagnostics, Inc. — ADVIA Centaur Anti-Thyroid Peroxidase II (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoShenzhen Zhenxing Ruitong Technology Co., Ltd. — MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoThe Binding Site Group , Ltd. — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoNeurovalens Limited — Modius Lean (510k cleared)

    Product code: SFW. Advisory committee: Gastroenterology, Urology. Type: Direct

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoElectrogenics Labs, Ltd. — MOSkin Radiation Measurement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoSinaptic Surgical — Osteotomy Wedge System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoRemi — Remi Custom Night Guard (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoAdin Dental Implant Systems , Ltd. — Adin Customized Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoShenzhen Qianyu Technology Co., Ltd. — JOVS Electric Stimulation Beauty Device (JE2) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoS.I.N. Implant System Ltda — S.I.N. Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoProgram Insite, LLC — Program insite® Powder-Free, Disposable Nitrile Exam Gloves (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 17, 2025device 510k290d agoStryker Neurovascular — InZone IST Detachment System; IZDS Connecting Cable (510k cleared)

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

    full page →fda device 510k ↗

    Week of Oct 20, 2025

    25
    ›Oct 20, 2025device 510k287d agoVascular Flow Technologies Limited — Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 20, 2025device 510k
    ← prev
    page 70 of 100
    next →
    287d ago
    Avatar Medical — brAIn™ Shoulder Positioning (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 20, 2025device 510k287d agoAVAVA, Inc. — AVAVA™ Skin Treatment System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 20, 2025device 510k287d agoSanhe Lefis Electronics Co., Ltd. — Q-Switched Nd: YAG Laser machine (LFS-C13U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 20, 2025device 510k287d agoAllumin8, Inc. — A8 INTEGR8™ Porous Pedicle Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 20, 2025device 510k287d agoInkspace Imaging, Inc. — InkSpace Imaging Small Body Array (SBA12PH30x) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 20, 2025device 510k287d agoFreyja Healthcare, LLC — VereSee Optical Veres Needle and Endoscopic Camera (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 20, 2025device 510k287d agoFeeltech Co., Ltd. — Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoOlympus Medical Systems Corporation — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoMIPM Mammendorfer Institut für Physik und Medizin GmbH — Neuromuscular Transmission Monitor TOF3D (2510091) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoAstura Medical — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoSimplivia Healthcare , Ltd. — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (510k cleared)

    Product code: ONB. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoMedivis, Inc. — NeuroAlign software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoMedos International SARL — TriALTIS™ Spine System (510k cleared)

    Product code: NKB. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoEdwards Lifesciences — HemoSphere Stream Module (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoBodycad Laboratories, Inc. — Fine TTO™ (510k cleared)Barr Laboratories Inc

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoAevumed, Inc. — Aevumed FASE Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoCardiocycle Medical(Suzhou) Co., Ltd. — Introducer Sheath Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 21, 2025device 510k286d agoLivsmed, Inc. — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k285d agoProsidyan, Inc. — FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute (510k cleared)

    Product code: MQV. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k285d agoYorlabs, Inc. — XC11 ICE System, USA (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k285d agoZeus Scientific — Alegria Flash CTD Screen (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k285d agoImeka Solutions, Inc. — ANDI 2.0 (510k cleared)UL Solutions Inc.

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k285d agoQIAGEN GmbH — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 22, 2025device 510k285d agoGenesys Spine — SIros-X System (510k cleared)

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

    full page →fda device 510k ↗
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    $FRTRY
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