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

NUC 2020-04-27

Agape Warming Personal Lubricant

Applicant CC Wellness, LLC

K-Number K200208

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QEP 2020-04-27

binx io CT/NG Assay and binx io CT/NG System

Applicant Binx Health, Inc.

K-Number K200533

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BSO 2020-04-27

Percutaneous Introducer

Applicant Epimed International, Inc.

K-Number K200624

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CCK 2020-04-27

Capnostream 35 Portable Respiratory Monitor

Applicant Oridion Medical 1987 , Ltd.

K-Number K200594

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MWI 2020-04-27

Oxi-W System

Applicant Ld Technology, LLC

K-Number K200141

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KKX 2020-04-26

ControlRad Sterile Cover

Applicant Controlrad, Inc.

K-Number K200238

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QGH 2020-04-26

MECTA Sigma

Applicant Mecta Corporation

K-Number K192834

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MJN 2020-04-25

Gatekeeper Balloon Catheter

Applicant Arch Catheter, LLC

K-Number K192786

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LZO 2020-04-25

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar

Applicant Microport Orthopedics, Inc.

K-Number K200007

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HCG 2020-04-25

i-ED COIL

Applicant Kaneka Pharma America, LLC

K-Number K192068

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LZA 2020-04-25

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K200581

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PZM 2020-04-24

PGDx elio tissue complete

Applicant Personal Genome Diagnostics

K-Number K192063

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