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

NKB 2017-08-01

M.U.S.T. Combined Set Screws

Applicant Medacta International S.A.

K-Number K171758

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JWY 2017-08-01

Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K171906

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EIH 2017-08-01

DD cubeX2 HS

Applicant Dental Direkt GmbH

K-Number K170885

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FGE 2017-07-31

Nasal Pancreatic Drainage Set

Applicant Cook Ireland, Ltd.

K-Number K171623

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LZA 2017-07-31

Xingyu Nitrile Powder Free Patient Examination Gloves, White color

Applicant Shandong Xingyu Gloves Co., Ltd.

K-Number K171615

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ITX 2017-07-31

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range

Applicant Koelis

K-Number K171040

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FDX 2017-07-31

Bronchi and Gastrointestinal Cytology Brush

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K-Number K171607

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DYB 2017-07-31

Performer Introducer

Applicant Cook Incorporated

K-Number K171999

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KCT 2017-07-31

Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator

Applicant Advanced Sterilization Products

K-Number K163598

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CBK 2017-07-31

bellavista 1000

Applicant Imtmedical AG

K-Number K163127

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FPA 2017-07-31

Carefusion NeutraClear Needle-free connector

Applicant Cair Lgl

K-Number K171132

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NFO 2017-07-31

NuBODY Skin Toning Device

Applicant Carol Cole Company Dba Nuface

K-Number K171588

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