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 2022-08-04

Bloomi Smooth Water Based Lubricant

Applicant The Bloomi Inc..

K-Number K221328

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DFH 2022-08-04

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Applicant Diazyme Laboratories, Inc.

K-Number K220001

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ODG 2022-08-04

Endoscope Model EG-580UT and Endoscope Model EG-580UR

Applicant Fujifilm Corporation

K-Number K221952

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NUH 2022-08-04

Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)

Applicant Well-Life Healthcare Limited

K-Number K220524

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MEH 2022-08-04

Actera™ hip system

Applicant Conformis, Inc.

K-Number K221104

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PBF 2022-08-04

CenterMed Patient Matched Assisted Surgical Planning (ASP) System

Applicant Centermed, Inc.

K-Number K211614

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DSY 2022-08-04

exGraft, exGraft Carbon

Applicant Peca Labs

K-Number K221628

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QEW 2022-08-04

Mini-ClotTriever Thrombectomy System

Applicant Inari Medical

K-Number K220887

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QDD 2022-08-04

MDHearingAid app, MDHearingAid Smart hearing aids

Applicant Mdhearingaid

K-Number K220303

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DQA 2022-08-04

Masimo CARESCAPE SpO2 – Masimo with SpHb

Applicant Masimo Corporation

K-Number K221953

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GWJ 2022-08-03

QScreen

Applicant Path Medical GmbH

K-Number K220139

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FRG 2022-08-03

Solidence Multipockets

Applicant Solidence Surgical Corporation

K-Number K191131

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