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

BZD 2021-01-29

Luna® G3 BPAP 25A

Applicant 3B Medical, Inc.

K-Number K201620

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FYC 2021-01-29

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back

Applicant Wildcat Ppe, LLC

K-Number K202310

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LNH 2021-01-29

i_Space 1.5T Superconducting Magnetic Resonance Imaging System

Applicant Mri Division,Beijing Wandong Medical Technology Co., Ltd.

K-Number K192650

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HAW 2021-01-29

Disposable Pre-calibrated Suction

Applicant Brainlab AG

K-Number K201752

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FXX 2021-01-29

Protective Face Mask for Medical Use

Applicant Hunan Heng Chang Pharmaceutical Co., Ltd.

K-Number K202358

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QLX 2021-01-29

cobas BKV

Applicant Roche Molecular Systems, Inc.

K-Number K203220

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ODP 2021-01-29

BEE Cages

Applicant NGMedical GmbH

K-Number K200429

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HKI 2021-01-29

VX650

Applicant Luneau Technology Operations

K-Number K202221

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QIH 2021-01-29

Visage Breast Density

Applicant Visage Imaging GmbH

K-Number K201411

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CBK 2021-01-29

Ventway Sparrow

Applicant Inovytech Medical Solutions , Ltd.

K-Number K202970

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GEI 2021-01-29

DEX Device

Applicant Dex Surgical

K-Number K191878

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GEX 2021-01-29

Rapid Acoustic Pulse Device

Applicant Soliton, Inc.

K-Number K201801

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