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

DFH 2017-11-17

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K171742

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LZA 2017-11-17

Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves

Applicant Smart Glove Corporation Sdn. Bhd.

K-Number K171743

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NUH 2017-11-17

Dr.MUSIC 3s

Applicant Smartmedicaldevice Co., Ltd.

K-Number K172451

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GDW 2017-11-17

AEON Endoscopic Stapler

Applicant Lexington Medical, Inc.

K-Number K171589

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OBR 2017-11-17

SleepRight ProRx Custom Dental Guard

Applicant Splintek, Inc.

K-Number K172223

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GEX 2017-11-17

DEKA SMARTXIDE TOUCH

Applicant El.En Electronic Engineering Spa

K-Number K172362

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PSQ 2017-11-17

Duravess bovine pericardial vascular patch

Applicant Edwards Lifesciences, LLC

K-Number K172660

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DQO 2017-11-17

Langston dual lumen catheter

Applicant Vascular Solutions, Inc.

K-Number K170544

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KPS 2017-11-17

Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173023

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POV 2017-11-17

Trak Plus Male Fertility Testing System

Applicant Sandstone Diagnostics, Inc.

K-Number K172514

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IYO 2017-11-17

CMS600P2 B-Ultrasound Diagnostic System

Applicant Contec Medical Systems Co.,Ltd

K-Number K170856

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KNS 2017-11-17

Single Use Electrosurgical knife

Applicant Olympus Medical Systems Corp.

K-Number K171158

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