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

FGE 2022-05-06

Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K211021

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NBW 2022-05-06

IWL2020 Blood Glucose Monitoring System

Applicant Roche Diabetes Care, Inc.

K-Number K203711

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GXY 2022-05-06

Disposable EEG cable

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K-Number K213884

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MUD 2022-05-06

Masimo O3 Regional Oximeter System

Applicant Masimo Corporation

K-Number K214072

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LQK 2022-05-06

Invu by Nuvo

Applicant Nuvo- Group , Ltd.

K-Number K221046

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QCI 2022-05-06

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

Applicant Neuronetics, Inc.

K-Number K212289

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LLZ 2022-05-06

KEOPS Balance Analyzer 3D

Applicant S.M.A.I.O

K-Number K213975

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DWC 2022-05-06

Quantum Heater-Cooler

Applicant Spectrum Medical , Ltd.

K-Number K212657

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GWQ 2022-05-06

WAVi SCAN EEG System and Accessories

Applicant Wavi Co.

K-Number K213900

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JAK 2022-05-06

NewTom 7G

Applicant Cefla S.C.

K-Number K220664

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NUC 2022-05-06

Astroglide Glycerin & Paraben Free

Applicant Biofilm, Inc.

K-Number K220653

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OVD 2022-05-06

PISCES-SA Standalone ALIF Interbody System

Applicant Osseus Fusion Systems

K-Number K213935

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