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

GCJ 2020-03-20

EnlightenVue Microendoscopy System

Applicant Enlightenvue, Inc.

K-Number K192300

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NKB 2020-03-20

Nano FortiFix® System

Applicant Nanovis Spine, LLC

K-Number K193211

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JAK 2020-03-20

Hepatic VCAR

Applicant GE Medical Systems SCS

K-Number K193281

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GEI 2020-03-20

Encision AEM Monopolar Laparoscopic Instruments and Accessories

Applicant Encision Incorporated

K-Number K191612

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NTK 2020-03-20

iTero Element 5D

Applicant Align Technology, Inc.

K-Number K193659

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NBW 2020-03-20

Bioland Blood Glucose Monitoring System

Applicant Bioland Technology, Ltd.

K-Number K191657

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LZA 2020-03-20

GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K193121

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NXC 2020-03-20

Clearform Aligners

Applicant Motor City Lab Works

K-Number K191838

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KPR 2020-03-20

MULTIX Impact

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193089

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KPS 2020-03-20

Symbia 6.7

Applicant Siemens Medical Solutions USA, Inc.

K-Number K200474

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HWC 2020-03-20

T2 ICF

Applicant Stryker GmbH

K-Number K193366

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QHE 2020-03-20

Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner

Applicant Materialise NV

K-Number K193560

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