Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

GEI 2024-11-01

Legend X Desktop System

Applicant Pollogen, Ltd.

K-Number K243217

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HSN 2024-11-01

Prophecy Surgical Planning System

Applicant Wright Medical Technology, Inc. (Stryker)

K-Number K241999

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ONW 2024-11-01

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

Applicant Quanta Dialysis Technologies, Ltd.

K-Number K242269

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KLE 2024-11-01

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)

Applicant Spident Co., Ltd.

K-Number K242675

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DQK 2024-11-01

Affera Integrated Mapping System; Impedance Localization Patch Kit

Applicant Medtronic, Inc.

K-Number K241828

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HQD 2024-11-01

Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses

Applicant Acuity Polymers, Inc.

K-Number K242393

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HRS 2024-11-01

Osteotomy Truss System (OTS)

Applicant 4Web Medical, Inc.

K-Number K240388

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KOB 2024-11-01

AMT Low-Profile Suprapubic Catheter & Drainage Set

Applicant Applied Medical Technology, Inc.

K-Number K240514

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DRF 2024-11-01

EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K-Number K240366

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DXF 2024-11-01

VersaCross RF Wire

Applicant Baylis Medical Company

K-Number K242076

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HTN 2024-11-01

EXPERT - Flexible Joint Fixation System

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K242311

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KPR 2024-11-01

uDR 780i

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K241068

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