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

FMF 2024-03-06

Insulin Syringe

Applicant Spm Medicare Pvt. , Ltd.

K-Number K233794

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IYO 2024-03-06

EdgeFlow UH10

Applicant Edgecare, Inc.

K-Number K231677

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HHW 2024-03-06

Gynethotics Pessary

Applicant Cosm Medical

K-Number K231786

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PAY 2024-03-06

CurrentBody Skin RF

Applicant El Global Trade, Ltd.

K-Number K232424

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GEI 2024-03-06

Disposable Bipolar Forceps

Applicant Jiangsu Hope Biomedical Science & Technology Co., Ltd.

K-Number K232703

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ODC 2024-03-06

Defendo Single Use Cleaning Adapter for Olympus Endoscopes

Applicant STERIS Corporation

K-Number K240352

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ODC 2024-03-06

Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector

Applicant Medivators (A Subsidiary of Steris Corporation)

K-Number K232004

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HBF 2024-03-06

evoDrill Cranial Perforator

Applicant Evonos GmbH & Co. KG

K-Number K231403

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LHI 2024-03-06

BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device

Applicant Care Fusion

K-Number K233021

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CEC 2024-03-06

Access Free T4

Applicant Beckman Coulter, Inc.

K-Number K240273

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NGL 2024-03-06

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

Applicant Assure Tech., LLC

K-Number K240351

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FBN 2024-03-06

Choledochoscope System

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K231497

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