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

KGC 2019-04-10

PUMA-G System

Applicant Coaptech, LLC

K-Number K183057

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DRE 2019-04-10

S-MAK XL

Applicant Merit Medical Systems, Inc.

K-Number K190175

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MXC 2019-04-10

Confirm Rx Insertable Cardiac Monitor

Applicant Abbott (St. Jude Medical)

K-Number K190295

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EFB 2019-04-10

PROPHYflex 4

Applicant Kaltenbach & Voigt GmbH

K-Number K181110

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NKG 2019-04-10

M.U.S.T. MINI Posterior Cervical Screws System

Applicant Medacta International S.A.

K-Number K190631

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SCL 2019-04-10

Oryum and Ovem Epidermal Deri Prick Test Applicator

Applicant Allergy & Applicator Depot, LLC

K-Number K182582

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NBW 2019-04-10

GLUCOCARD® W onyx Blood Glucose Monitoring System

Applicant Arkray Factory, Inc.

K-Number K183306

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FMI 2019-04-09

Adult Intraosseous Infusion Device

Applicant Einstein Works, LLC

K-Number K182770

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OLO 2019-04-09

ExcelsiusGPS

Applicant Globus Medical, Inc.

K-Number K190653

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IYN 2019-04-09

DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K183660

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DXN 2019-04-09

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K181832

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LXJ 2019-04-09

Vera

Applicant Reflexion Health, Inc.

K-Number K182333

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