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

MHX 2018-12-21

North-vision Multi-parameter Patient Monitor

Applicant North-Vision Tech., Inc.

K-Number K173036

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FBK 2018-12-21

Clear-Jet Injection Catheter

Applicant Finemedix Co., Ltd.

K-Number K181690

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HRX 2018-12-21

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)

Applicant Stryker Corporation

K-Number K181752

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LLZ 2018-12-21

4D View

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K182750

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JOW 2018-12-21

Pulse Rx 2.0, Pulse Pro Rx 2.0

Applicant NormaTec Industries, LP

K-Number K183328

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EBI 2018-12-21

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White

Applicant Juvora, Ltd.

K-Number K181331

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QEW 2018-12-21

The ICHOR Panacea Vascular Embolectomy Catheter System

Applicant Ichor Vascular, Inc.

K-Number K182167

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PLV 2018-12-21

Neocis Guidance System

Applicant Neocis, Inc.

K-Number K182776

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GZL 2018-12-20

microTargeting Guideline 4000 5.0 System

Applicant FHC, Inc.

K-Number K183123

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DRE 2018-12-20

Dilator Sets

Applicant Cook Incorporated

K-Number K183036

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MAX 2018-12-20

Curiteva Lumbar Interbody Fusion System

Applicant Curiteva, LLC

K-Number K181589

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DQX 2018-12-20

Reuter Tip Deflecting Wire Guide

Applicant Cook Incorporated

K-Number K180830

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