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

ODP 2019-02-14

Shoreline Cervical Interbody RT System

Applicant SeaSpine Orthopedics Corporation

K-Number K183083

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LNH 2019-02-14

MyoStrain 5.1

Applicant Myocardial Solutions

K-Number K182756

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HRS 2019-02-13

EPIC Extremity Fusion Plate System

Applicant Epic Extremity, LLC

K-Number K182991

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JAK 2019-02-13

SnapShot Freeze 2

Applicant Ge Medical Systems, LLC

K-Number K183161

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LRK 2019-02-13

Kava and Kava with Herbst

Applicant Sketchpad Innovations, LLC

K-Number K182661

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MXA 2019-02-13

Fenom Pro Nitric Oxide Test

Applicant Spirosure, Inc.

K-Number K182874

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FMI 2019-02-13

U&U Blood Collection Sets

Applicant U&U Medical Technology Co, Ltd.

K-Number K181508

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OYX 2019-02-13

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

Applicant Bio-Rad Laboratories, Inc.

K-Number K181661

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KNT 2019-02-13

ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

Applicant Envizion Medical , Ltd.

K-Number K182915

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NKB 2019-02-13

NuVasive Reline System

Applicant Nu Vasive, Incorporated

K-Number K182974

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DXN 2019-02-12

FORA P100 Blood Pressure Monitoring System

Applicant Taidoc Technology Corporation

K-Number K182934

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GEI 2019-02-12

Aurora Evacuator

Applicant Rebound Therapeutics

K-Number K190075

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