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

LLZ 2021-05-21

Universal Viewer

Applicant GE Healthcare

K-Number K211312

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LFL 2021-05-21

Ultrasonic Surgical Aspirator System

Applicant Smtp Technology Co., Ltd.

K-Number K202299

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MJN 2021-05-21

Neurescue device

Applicant Neurescue Aps

K-Number K210358

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IZL 2021-05-21

Rover

Applicant Micro-X Limited

K-Number K211423

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ITI 2021-05-21

JWX-1 Plus (Navigo 16/Navigo 24)

Applicant Yamaha Motor Co., Ltd.

K-Number K203806

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ONF 2021-05-21

IPL Hair Removal Device (Model: KCA423)

Applicant Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.

K-Number K210119

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IOR 2021-05-21

Manual Wheelchair, Model A011

Applicant Ningbo Shenyu Medical Equipment Co.,Ltd

K-Number K201461

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DQK 2021-05-21

Zio ECG Utilization Software (ZEUS) System

Applicant iRhythm Technologies, Inc.

K-Number K202527

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LFL 2021-05-21

Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray

Applicant Ethicon Endo-Surgery, LLC

K-Number K211273

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DSH 2021-05-21

Zio Monitor

Applicant iRhythm Technologies, Inc.

K-Number K202359

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EBW 2021-05-21

Impla-NX (Model: ISE-270M)

Applicant Micro-Nx Co., Ltd.

K-Number K201192

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LLZ 2021-05-20

Xoran Workstation, Model 10050

Applicant Xoran Technologies, LLC

K-Number K210257

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