Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

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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PIF 2019-04-09

ENConnect 40 mm Screw Cap to ENPlus Adapter

Applicant Cedic S.R.L.

K-Number K190327

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MCW 2019-04-09

Pantheris SV

Applicant Avinger, Inc.

K-Number K182341

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LEJ 2019-04-08

Ergoline Sunrise 7200 Hybrid Technology

Applicant Jk-Holding GmbH

K-Number K183539

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