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

LZO 2020-02-27

Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

Applicant Biomet UK, Ltd.

K-Number K192683

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FBK 2020-02-27

Disposable Sclerotherapy Needle

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K190032

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JZO 2020-02-27

Elecsys Anti-TSHR

Applicant Roche Diagnostics

K-Number K193313

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GCA 2020-02-27

Fusion Quattro Extraction Balloon

Applicant Wilson-Cook Medical, Inc.

K-Number K200247

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HWC 2020-02-27

Omnia Medical Trauma Screws

Applicant Omnia Medical, LLC

K-Number K192096

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NRY 2020-02-27

Penumbra System Penumbra JET 7X

Applicant Penumbra, Inc.

K-Number K191946

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QKE 2020-02-27

Proov Test

Applicant Mfb Fertility, Inc.

K-Number K191462

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MWI 2020-02-27

Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories

Applicant Masimo Corporation

K-Number K193242

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ODA 2020-02-27

INTELLIO Tablet Application

Applicant Smith & Nephew

K-Number K192876

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QJP 2020-02-27

CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm

Applicant Medos International SARL

K-Number K192804

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NHA 2020-02-26

Luna Dental Implant System- Healing Abutment

Applicant Shinhung Mst Co., Ltd.

K-Number K200189

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DZJ 2020-02-26

VSP System

Applicant 3D Systems

K-Number K192192

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