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

FXX 2019-05-27

Surgical Face Mask

Applicant Wuhan Dymex Healthcare Co., Ltd.

K-Number K182515

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DTQ 2019-05-24

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

Applicant Spectrum Medical , Ltd.

K-Number K190282

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ITX 2019-05-24

Envision ultrasound pad and cover

Applicant Civco Medical Solutions

K-Number K190802

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KGO 2019-05-24

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove

Applicant Molnlycke Health Care Us, LLC

K-Number K190077

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HQF 2019-05-24

LightLas Pattern Scanning System - TruScan Pro

Applicant Light-Med(Usa), Inc.

K-Number K190448

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KOD 2019-05-24

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

Applicant Teleflexmedical, Inc.

K-Number K181979

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GEX 2019-05-24

Soliton Acoustic Wave Device

Applicant Soliton, Inc.

K-Number K190542

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DZE 2019-05-24

Conical Plus Implant System

Applicant Osseofuse International, Inc.

K-Number K181157

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LYZ 2019-05-24

Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Applicant Jiangxi Jaysun Medcare Co., Ltd.

K-Number K182575

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HWC 2019-05-24

InCore® Lapidus Sterile Kits

Applicant Nextremity Solutions, Inc.

K-Number K190231

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LZO 2019-05-24

MobileLink Acetabular Cup System

Applicant Waldemar Link GmbH & Co. KG

K-Number K182321

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ODW 2019-05-24

TruDiagnosis System

Applicant Akonni Biosystems, Inc.

K-Number K183530

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