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

QEP 2021-12-17

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit

Applicant Rheonix, Inc.

K-Number K193081

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LZA 2021-12-17

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves

Applicant Hycare International Co., Ltd.

K-Number K211209

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JAK 2021-12-17

Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition

Applicant Ge Medical Systems, LLC

K-Number K213715

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FXX 2021-12-17

Surgical Face Mask

Applicant Zhongshan Saifute Labor Protective Articles Co., Ltd.

K-Number K212059

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QJP 2021-12-17

EMBOGUARD Balloon Guide Catheter

Applicant Neuravi Limited

K-Number K212340

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MXA 2021-12-17

NObreath®

Applicant Bedfont Scientific, Ltd.

K-Number K203695

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MOS 2021-12-17

InkSpace Imaging Pediatric Body Array

Applicant Inkspace Imaging, Inc.

K-Number K213397

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GEI 2021-12-17

Single Use Electrosurgical Knife with Fluid Pump System

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

K-Number K211172

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QPC 2021-12-17

Donagamex Blue Performance Protective Gown

Applicant Dong Nai Garment Corporation (Donagamex)

K-Number K203821

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NEW 2021-12-17

PDO Max Suture with Dual Needle

Applicant Pdo Max, Inc.

K-Number K210871

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EKX 2021-12-17

Cordless Prophy System, Model: i-Polish

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K211531

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DTZ 2021-12-17

Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2

Applicant Qura S.R.L

K-Number K203424

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