Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

LZA 2021-07-29

Blue Nitrile Exam Gloves

Applicant Jiangxi Surefine Medical Co., Ltd.

K-Number K211341

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IYE 2021-07-29

Zap-X Radiosurgical System

Applicant Zap Surgical Systems, Inc.

K-Number K211663

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MUH 2021-07-29

CRUXVIEW

Applicant Cruxell Corp.

K-Number K211317

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LYZ 2021-07-29

Vinyl compound examination gloves

Applicant Hebei Titans Hongsen Medical Technology Co., Ltd.

K-Number K211229

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OLO 2021-07-29

NuVasive Pulse System

Applicant Nu Vasive, Incorporated

K-Number K210574

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CAC 2021-07-29

Hemafuse System

Applicant Sisu Global Health

K-Number K210862

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DXN 2021-07-29

Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K210770

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KTT 2021-07-29

SMART Taylor Spatial Frame

Applicant Smith & Nephew, Inc.

K-Number K210953

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MSB 2021-07-29

OCS Lung Solution

Applicant TransMedics, Inc.

K-Number K211314

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DYH 2021-07-29

FiteBac CC OrthoSeal

Applicant Largent Health, LLC

K-Number K210115

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DZE 2021-07-29

BTI Extra-Short Dental Implant System UnicCa

Applicant B.T.I. Biotechnology Institute, Sl.

K-Number K202825

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JWH 2021-07-29

GMK Sphere Revision

Applicant Medacta International S.A.

K-Number K211664

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