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calendar

23 catalysts · 23 device 510k

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2026-08-24: 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: 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: 1 catalyst2026-10-01: 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: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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Week of May 12, 2025

23
›May 16, 2025device 510k472d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoBrainlab AG — Mixed Reality Spine Navigation (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoCellah Medical Co., Ltd. — BLESSING System (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoVenocare, Inc. — Ruby Intravascular Catheter (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoIorbit Digital Technologies Private Limited — iBSM (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoMedicatech USA, Inc. — MasteRad MiniX Mobile Digital Imaging System (Mini-X) (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoSENTINEL CH. SpA — Cystatin C (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoShanghai United Imaging Healthcare Co., Ltd. — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoFujirebio Diagnostics,Inc. — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (510k cleared)Co-Diagnostics, Inc.

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoByonyks Pvt, Ltd. — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoWaldemar Link GmbH & Co. KG — MobileLink Acetabular Cup System - inhouse coatings (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoVarian Medical Systems — Mobius3D (4.1) (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoBreas Medical AB — Clearo (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoInfervision Medical Technology Co., Ltd. — InferRead Lung CT.AI (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoOrtoma AB — OTS Hip (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoEncore Medical L.P. — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (510k cleared)Encore Medical, Inc.

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoHaolang Medical USA Corporation — Hemodialysis Catheter (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoEsaote, S.p.A. — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoShenzhen Desida Technology Co., Ltd. — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoBiosphere Medical, S.A. — Embosphere Microspheres (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoArthrex, Inc. — Arthrex Spine Endoscope (510k cleared)

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

full page →fda device 510k ↗
›May 16, 2025device 510k472d agoAustin Medical Ventures, Inc. — Synthecure Synthetic Calcium Sulfate (510k cleared)

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

full page →fda device 510k ↗
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