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calendar

14 catalysts · 10 device 510k · 4 approval

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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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  • device 510k10
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no tagged catalysts yet

Week of Jan 20, 2025

14
›Jan 24, 2025approval564d ago
MEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗
›Jan 24, 2025approval564d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗
›Jan 24, 2025approval564d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION

full page →lecanemab →fda approvals ↗
›Jan 24, 2025approval564d agoAVTOZMA (TOCILIZUMAB-ANOH) — FDA approvalAVTOZMA

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →AVTOZMA →fda approvals ↗
›Jan 24, 2025device 510k564d agoBridge TO Life, Ltd. — OrganProtex HTK Solution (510k cleared)

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

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoIndiba S. A. U. — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) (510k cleared)

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

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoRoche Diagnostics Operations — Tina-quant Lipoprotein(a) Gen.2 Molarity (510k cleared)Dawn Sea Therapeutics

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

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoZhejiang Curaway Medical Technology Co., Ltd. — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoElliquence, LLC — AxCess® Expandable Interbody System (510k cleared)

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

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoZhejiang Curaway Medical Technology Co., Ltd. — Bone Marrow Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoClearPoint Neuro, Inc. — ClearPoint System (Software Version 3.0) (510k cleared)ClearPoint Neuro, Inc.

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

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoIbex Medical Analytics , Ltd. — Galen™ Second Read™ (510k cleared)

Product code: QPN. Advisory committee: Pathology. Type: Traditional

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoMagentiq Eye, Ltd. — MAGENTIQ-COLO (ME-APDS) (510k cleared)

Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗
›Jan 24, 2025device 510k564d agoWuhan Guangdun Technology Co.,Ltd.. — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (510k cleared)

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

full page →fda device 510k ↗
$NVS156.79+0.29%
$CLPT
$NVS156.79+0.29%