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

GEX 2024-01-30

DermRays Revive

Applicant Wuhan Lotuxs Technology Co., Ltd.

K-Number K231910

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OVD 2024-01-30

E3D-A Interbody System

Applicant Evolution Spine

K-Number K232432

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JDQ 2024-01-30

VariTrax Sternal CircumFixation System

Applicant Circumfix Solutions, Inc.

K-Number K232986

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JXI 2024-01-29

Rebuilder Nerve Guidance Conduit

Applicant Celestray Biotech Company, LLC.,

K-Number K230794

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IYN 2024-01-28

Gem Flow Now (GEM2770-FN)

Applicant Synovis Micro Companies Alliance

K-Number K233394

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GEX 2024-01-27

Epilaser Pro

Applicant Epilady 2000, LLC

K-Number K233224

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KWQ 2024-01-26

MONDRIAN Anterior Lumbar Plate System

Applicant Ctl Medical Corporation

K-Number K231715

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JKA 2024-01-26

LifeOutcomes C-Quest Blood Culture Sampling Device

Applicant Lifeoutcomes, LLC

K-Number K231282

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LZA 2024-01-26

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs

Applicant Anhui Intco Medical Products Co., Ltd.

K-Number K233598

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HGX 2024-01-26

Perifit Pump

Applicant X6 Innovations

K-Number K231785

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KNT 2024-01-26

ViSiGi 3D Gastric Sizing Tube

Applicant Boehringer Laboratories

K-Number K234145

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LCX 2024-01-26

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

Applicant Nantong Egens Biotechnology Co., Ltd.

K-Number K232864

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