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

DQK 2019-11-27

Rhythmia HDxTM Mapping System

Applicant Boston Scientific Corporation

K-Number K192438

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GBM 2019-11-27

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter

Applicant Hangzhou Bever Medical Devices Co., Ltd.

K-Number K192468

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GWO 2019-11-27

Optimus NEURO System - Sterile Kit

Applicant Osteonic Co., Ltd.

K-Number K190811

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JWH 2019-11-27

World Knee Total Knee Systems

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K190577

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KPR 2019-11-27

EOSedge

Applicant Eos Imaging

K-Number K192079

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IYO 2019-11-27

Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K192791

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DXG 2019-11-27

Hypotension Decision Assist

Applicant Directed Systems, Ltd.

K-Number K190955

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DXN 2019-11-27

Upper Arm Blood Pressure Monitor

Applicant Famidoc Technology Company Limited

K-Number K191673

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ONF 2019-11-27

Multi-modality workstation

Applicant Beijing Superlaser Technology Co., Ltd.

K-Number K192519

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LOD 2019-11-27

Hi-Fatigue G Bone Cement

Applicant Osartis GmbH

K-Number K192379

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DSA 2019-11-27

ECG Cable

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K-Number K191428

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OLR 2019-11-27

Orapeutic

Applicant Forward Science

K-Number K191987

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