Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

DXN 2019-06-13

Full Automatic (NIBP) Blood Pressure Monitor-HL158UB

Applicant Health & Life Co., Ltd.

K-Number K190133

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GXQ 2019-06-13

XenoSure Dura Biologic Patch

Applicant LeMaitre Vascular, Inc.

K-Number K183513

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IYN 2019-06-13

Transcranial Doppler Ultrasound System

Applicant Shenzhen Delica Medical Equipment Co., Ltd.

K-Number K190228

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ODP 2019-06-13

Oyster ACIF Cage

Applicant Silony Medical GmbH

K-Number K182608

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KCT 2019-06-13

Sonopet iQ Sterilization Tray

Applicant Paragon Medical

K-Number K190667

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MAX 2019-06-13

ProLift® Expandable System

Applicant Life Spine, Inc.

K-Number K191005

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MYF 2019-06-13

SeraQuest HSV Type 2 Specific IgG

Applicant Quest International, Inc.

K-Number K181514

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LBH 2019-06-13

Restore Toothpaste

Applicant Dr. Collins, Inc.

K-Number K181965

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GEI 2019-06-13

Electrosurgical Generator

Applicant Fulwell, LLC

K-Number K183564

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LNH 2019-06-13

SyMRI

Applicant Syntheticmr AB

K-Number K191036

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FJL 2019-06-13

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Applicant Corinth Medtech, Inc.

K-Number K191341

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LLZ 2019-06-13

ClariCT.AI

Applicant Claripi, Inc.

K-Number K183460

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