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

NUC 2016-06-29

ally Liquid Personal Lubricant

Applicant Private Label Production, LLC

K-Number K160763

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KGE 2016-06-29

Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K161186

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CDZ 2016-06-29

ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K151986

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LFL 2016-06-29

HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length

Applicant Ethicon Endo-Suregery, LLC

K-Number K160752

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MAX 2016-06-29

Spinal Jaxx Interbody Fusion Device

Applicant Neuropro Spinaljaxx, Inc.

K-Number K152501

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QSY 2016-06-29

Nustat XR

Applicant Beeken Biomedical, LLC

K-Number K160578

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MQB 2016-06-28

SCATTER CORRECTION FOR CXDI SERIES

Applicant Canon, Inc.

K-Number K153312

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MEG 2016-06-28

Jeesung Safety Syringe and Single Use Needles

Applicant Jeesung Medical Co., Ltd.

K-Number K152606

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LLZ 2016-06-28

Surgical Navigation Advanced Platform (SNAP)

Applicant Surgical Theater, LLC

K-Number K160584

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EBZ 2016-06-28

LED Curing Light GT-2000

Applicant Monitex Industrial Co., Ltd.

K-Number K153078

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JOJ 2016-06-28

Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape

Applicant Canadian Technical Tape, Ltd.

K-Number K161024

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PMT 2016-06-28

VIDAS B.R.A.H.M.S. PCT (PCT)

Applicant bioMerieux, Inc.

K-Number K160911

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