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

JOJ 2017-11-17

Micro-MEC 1.8% Glutaraldehyde Monitor Strip

Applicant STERIS Corporation

K-Number K172472

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FRO 2017-11-17

Endoform Silver Dermal Template

Applicant Aroa Biosurgery

K-Number K172318

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KNT 2017-11-17

Gastric Sizing Balloon Catheter

Applicant Cook Incorporated

K-Number K173355

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LRX 2017-11-17

Bausch + Lomb Boston Scleral Lens Case

Applicant Bausch & Lomb, Incorporated

K-Number K173365

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MWI 2017-11-17

Masimo Root Monitoring System and Accessories

Applicant Masimo Corporation

K-Number K171121

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LNH 2017-11-17

Vantage Titan 3T, MRT-3010/A7, M-Power GX

Applicant Toshiba Medical Systems Corporation, Japan

K-Number K172878

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MOS 2017-11-17

Contour 24

Applicant Quality Electrodynamics, LLC

K-Number K173446

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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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