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

NQZ 2019-07-17

Fungitell STAT

Applicant Associates of Cape Cod, Inc.

K-Number K191167

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HRX 2019-07-17

Pegasus System

Applicant A.M. Surgical, Inc.

K-Number K191345

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MBI 2019-07-17

Xtreme-Loop

Applicant Xiros, Ltd.

K-Number K191053

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MQC 2019-07-17

The POD

Applicant Advanced Facialdontics, LLC

K-Number K182820

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DQO 2019-07-16

Impress Angiographic Catheter

Applicant Merit Medical Systems, Inc.

K-Number K191608

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PDQ 2019-07-16

ALARA Neuro Access Kit

Applicant SurGenTec, LLC

K-Number K190163

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NBY 2019-07-16

Biotex

Applicant Purgo Biologics, Inc.

K-Number K180992

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FLL 2019-07-16

Microlife Digital Infrared Ear Thermometer

Applicant Microlife Intellectual Property GmbH

K-Number K183663

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GDW 2019-07-16

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners

Applicant Davol Inc., Subsidiary of C.R. Bard

K-Number K191287

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NUC 2019-07-16

Sage 2-in-1 Personal Lubricant and Moisturizer

Applicant Fairhaven Health, LLC

K-Number K190150

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LJE 2019-07-16

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set

Applicant Cook Incorporated

K-Number K183051

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NKA 2019-07-16

iBreastExam

Applicant Ue Lifesciences, Inc.

K-Number K190575

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