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

OHT 2022-06-30

Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K

Applicant Shenzhen Fansizhe Science and Technology Co., Ltd.

K-Number K221569

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LCX 2022-06-30

hCG One Step Pregnancy Test

Applicant Healstone Biotech, Inc.

K-Number K212418

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DQX 2022-06-30

VASSALLO GT 018 Floppy

Applicant Filmecc Co., Ltd.

K-Number K213949

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DYB 2022-06-30

Epicardial Access System

Applicant Baylis Medical Company, Inc.

K-Number K213582

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LOX 2022-06-30

NC TREK NEO Coronary Dilatation Catheter

Applicant Abbott Vascular

K-Number K220634

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EIH 2022-06-29

Coloring Liquid

Applicant Dongguan Xiangtong Co., Ltd.

K-Number K220017

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LIT 2022-06-29

Ebony HP PTA OTW 0.035 Catheter

Applicant Natec Medical , Ltd.

K-Number K220410

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PDU 2022-06-29

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

Applicant Ra Medical Systems,Inc

K-Number K220544

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HGX 2022-06-29

Powered Breast Pump (Models 7V and 7X)

Applicant Haenim Co., Ltd.

K-Number K211016

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MOF 2022-06-29

RADIFOCUS Torque Device

Applicant Terumo Medical Products (Hangzhou) Co., Ltd.

K-Number K220934

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EHD 2022-06-29

CLAROX

Applicant Vsi Co., Ltd.

K-Number K221286

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OWB 2022-06-29

ARTIS pheno (VE21) System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K220409

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