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

LHN 2016-08-17

Sumitomo Proton Therapy System

Applicant Sumitomo Heavy Industries, Ltd.

K-Number K160612

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NUC 2016-08-17

Just Like Me Personal Lubricant

Applicant Wtfn-Dba Classic Erotica/Holiday Products

K-Number K161385

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JAK 2016-08-17

SUPRIA w/guideShot Option

Applicant Hitachi Medical Systems America, Inc.

K-Number K161748

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ITX 2016-08-17

UST-5550-R; UST-5536-R; L43K

Applicant Hitachi Aloka Medical America, Inc.

K-Number K152126

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FAJ 2016-08-17

Ambu USR, Ambu M

Applicant Ambu A/S

K-Number K160766

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HRS 2016-08-17

Alians Elbow Locking Plating System

Applicant Newclip Technics

K-Number K152289

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KXK 2016-08-17

SPEC Model M23

Applicant Source Production and Equipment Co., Inc.

K-Number K161396

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JAA 2016-08-17

Uroview FD

Applicant Pausch Medical GmbH

K-Number K161019

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FRO 2016-08-17

LUOFUCON Silicone Ag foam dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K160022

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IMI 2016-08-17

Accent XL

Applicant Alma Lasers, Inc.

K-Number K160075

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LLZ 2016-08-17

PACS CORE/ENCORE

Applicant Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

K-Number K161518

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FLL 2016-08-16

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

Applicant Kaz USA, Inc., A Helen of Troy Company

K-Number K161933

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