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calendar

19 catalysts · 16 device 510k · 3 approval

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2026-08-10: 75 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: 16 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 510k16
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no tagged catalysts yet

Week of Apr 7, 2025

19
›Apr 10, 2025approval488d ago
VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Apr 10, 2025approval488d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗
›Apr 10, 2025approval488d agoLOPRESSOR (METOPROLOL TARTRATE) — FDA approvalmetoprolol tartrate

Sponsor: RUBICON RESEARCH. Form: SOLUTION. Route: ORAL

full page →metoprolol tartrate →fda approvals ↗
›Apr 10, 2025device 510k488d agoBrain Electrophysiology Laboratory Company, LLC — NEAT 001 (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoKyocera Medical Technologies Inc. (KMTI) — Skyway Anterior Cervical Plate System (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoKyocera Medical Technologies, Inc. — Tesera-k SC System (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoDonnevie Medical Technology (Shanghai) Co. , Ltd. — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoCanon Medical Informatics, Inc. — Vitrea CT VScore (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoOrthofix Srl — FitboneTM Trochanteric (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoVizionfocus, Inc. — Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoTriMed, Inc. — TriMed® Compression Screws (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoSiemens Medical Solutions USA, Inc. — syngo.CT LVO Detection (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoKyocera Medical Technologies, Inc. — Initia T3 Acetabular Hemispherical Shell System (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoJiangsu Ruifuda Medical Device Co., Ltd. — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoCuremetrix, Inc. — cmAngio® (V1.6) (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoAtriCure, Inc. — cryoICE cryoXT cryoablation probe (cryoXT) (510k cleared)AtriCure, Inc.

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoPremium Plus (Dongguan) Limited — LED Curing Light (C01-X, C02-X) (510k cleared)

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

full page →fda device 510k ↗
›Apr 10, 2025device 510k488d agoChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd — XNY Disposable Gastric Calibration Tube (510k cleared)

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

full page →fda device 510k ↗
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