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

FYA 2022-05-04

Plus Medical Chemotherapy Gown

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K-Number K211036

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JSM 2022-05-04

BioTeke Sterile Disposable Virus Sampling Kit

Applicant Bioteke Corporation (Wuxi) Co., Ltd.

K-Number K211707

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MLZ 2022-05-04

Vista Ophthalmics Vitrectomy Probe

Applicant Vista Ophthalmics, LLC

K-Number K220030

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FLL 2022-05-04

Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311

Applicant Alicn Medical Shenzhen, Inc.

K-Number K212257

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PNO 2022-05-04

Serranator PTA Serration Balloon Catheter

Applicant Cagent Vascular, LLC

K-Number K220704

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DXN 2022-05-04

LiveOne

Applicant Livemetric (Medical) S.A.

K-Number K201302

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OWB 2022-05-03

Cardiovascular Angiography System

Applicant Allengers Medical Systems Limited

K-Number K220311

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GEX 2022-05-03

ECHOLASER X4

Applicant Elesta S.P.A

K-Number K213594

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KRO 2022-05-03

LINK Endo-Model EVO Knee System

Applicant Waldemar Link GmbH & Co. KG

K-Number K220628

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DQK 2022-05-03

ECGenius System

Applicant Cath Vision Aps

K-Number K220306

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JOY 2022-05-03

X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

Applicant Scopio Labs , Ltd.

K-Number K220013

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QOI 2022-05-03

Orchid Safety Release Valve(TM)

Applicant Linear Health Sciences, LLC

K-Number K212064

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