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

MSS 2020-06-04

bioli lOL Delivery System

Applicant Ast Products, Inc.

K-Number K200057

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DJG 2020-06-04

LZI Tramadol Enzyme Immunoassay

Applicant Lin-Zhi International, Inc.

K-Number K201223

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LZC 2020-06-04

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate

Applicant Ever Global (Vietnam) Enterprise Corp

K-Number K193555

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NBW 2020-06-04

Livongo Blood Glucose Monitoring System (BG1000)

Applicant Livongo Health, Inc.

K-Number K200277

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GEX 2020-06-04

Oxylight

Applicant Raja Trading Company, Inc.

K-Number K200104

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MBI 2020-06-04

HEALIX ADVANCE Anchor with DYNATAPE Suture

Applicant Medos International SARL

K-Number K200949

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GXR 2020-06-03

Flap Fixator, Burr Hole Cover

Applicant Ossaware Biotech Co., Ltd.

K-Number K192310

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LNH 2020-06-03

Vantage Orian 1.5T, MRT-1550, V6.0

Applicant Canon Medical Systems Corporation

K-Number K193021

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NUC 2020-06-03

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant

Applicant CC Wellness, LLC

K-Number K200602

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QFO 2020-06-03

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

Applicant Chembio Diagnostic Systems

K-Number K200506

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IYE 2020-06-03

Thales 3D Mr Scanner

Applicant Lap GmbH Laser Applikationen

K-Number K200907

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HAW 2020-06-03

StealthStation Cranial Software v1.3.0

Applicant Medtronic Navigation, Inc.

K-Number K201175

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