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

LZA 2021-03-30

Blue Nitrile Exam Glove, Powder Free

Applicant Great Harvest Trading Co., Ltd.

K-Number K210058

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LQY 2021-03-30

BOMEDENT Apex locator, WISMY Apex locator

Applicant Changzhou Bomedent Medical Technology Co.,Ltd

K-Number K203836

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MBH 2021-03-30

EMPOWR Porous Femur with HAnano SurfaceTM

Applicant Encore Medical L.P.

K-Number K210308

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FXX 2021-03-30

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask

Applicant Iob Medical, Inc.

K-Number K201896

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LNS 2021-03-30

Modulith SLX-F2

Applicant Karl Storz Endoscopy America

K-Number K201001

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FXX 2021-03-30

Surgical Face Masks

Applicant Intco Medical(Hk) Co., Ltd.

K-Number K202708

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DWJ 2021-03-30

3M Bair Hugger Temperature Management System (Model 675)

Applicant 3M Company

K-Number K210603

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EBI 2021-03-30

E-Denture Pro

Applicant Envisiontec GmbH

K-Number K203641

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GEX 2021-03-30

PicoSure Workstation

Applicant Cynosure, LLC

K-Number K210226

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OAP 2021-03-29

LaserCap Family of Lasers 300, 224, 120 & 80

Applicant Transdermal Cap, Inc.

K-Number K203826

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KPS 2021-03-29

StarGuide

Applicant GE Healthcare

K-Number K210173

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OMC 2021-03-29

REMI

Applicant Epitel, Inc.

K-Number K203827

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