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

QAS 2021-07-08

HALO

Applicant Nicolab B.V.

K-Number K211788

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FXX 2021-07-08

Medical surgical mask

Applicant Shantou T&K Medical Equipment Factory Co.,Ltd

K-Number K210380

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HGX 2021-07-08

Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)

Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd.

K-Number K203148

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IYO 2021-07-08

iSR'obot Mona Lisa 1.0

Applicant Biobot Surgical Pte., Ltd.

K-Number K203659

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CAF 2021-07-08

Nebulizer Kit

Applicant Excellentcare Medical (Huizhou) , Ltd.

K-Number K192971

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OLO 2021-07-08

StealthStation Spinous Process Clamps

Applicant Medtronic Navigation

K-Number K211442

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FCX 2021-07-08

END 200 Endoscopic Tubeset

Applicant Palliare , Ltd.

K-Number K202922

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HET 2021-07-08

SurroundScope System

Applicant 270surgical , Ltd.

K-Number K210104

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LLZ 2021-07-08

PRE-SURE

Applicant Lazarus 3D, Inc.

K-Number K201835

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IPF 2021-07-08

Nerve and Muscle Stimulator

Applicant Shenzhen Xft Medical Limited

K-Number K211094

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DQK 2021-07-08

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

Applicant Edwards Lfesciences

K-Number K211465

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DZE 2021-07-08

Straumann RidgeFit Implants

Applicant Institut Straumann AG

K-Number K211052

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