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

JDI 2020-03-20

CPT Hip System

Applicant Zimmer, Inc.

K-Number K191735

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LZA 2020-03-20

Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster

Applicant Sri Trang Gloves (Thailand) Public Company Limited

K-Number K193581

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LOD 2020-03-19

G1 40 Radiopaque Bone Cement

Applicant G21, S.R.L.

K-Number K193059

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HRS 2020-03-19

Park's Pectus System

Applicant Tdm Co., Ltd.

K-Number K191057

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HWC 2020-03-19

restor3d Metallic Interference Screw

Applicant Restor3D

K-Number K193491

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BTT 2020-03-19

F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K191818

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DRE 2020-03-19

Super Sheath

Applicant Togo Medikit Co., Ltd.

K-Number K200379

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LOD 2020-03-19

G3 40 Radiopaque Bone Cement

Applicant G21, S.R.L.

K-Number K193061

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GAW 2020-03-19

Deklene MAXX

Applicant Teleflex Medical

K-Number K193530

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JOW 2020-03-19

Compression Therapy Device

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K-Number K191856

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FPA 2020-03-19

IV Sets not made with PVC

Applicant B.Braun Medical, Inc.

K-Number K191658

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KNS 2020-03-19

Creo Electrosurgical System with HS1 Hemostasis Accessory

Applicant Creo Medical, Ltd.

K-Number K192905

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