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

FIP 2019-10-03

Millenium HX

Applicant Mar Cor Purification, Inc.

K-Number K192398

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OVD 2019-10-03

SAHARA Stabilization System

Applicant K2m, Inc.

K-Number K190179

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HRS 2019-10-03

Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module

Applicant Arthrex, Inc.

K-Number K191344

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IYE 2019-10-03

Mobius3D

Applicant Varian Medical Systems, Inc.

K-Number K192424

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LIT 2019-10-03

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters

Applicant Bard Peripheral Vascular, Inc.

K-Number K192318

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JAK 2019-10-03

XACT Robotic System

Applicant Xact Robotics, Ltd.

K-Number K191332

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NKB 2019-10-02

Momentum™ Posterior Spinal Fixation System

Applicant Ulrich Medical USA

K-Number K191932

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OHT 2019-10-02

Aimanfun Lumea Comfort

Applicant Kam Yuen Plastic Products , Ltd.

K-Number K190820

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CDD 2019-10-02

LIAISON Vitamin B12

Applicant DiaSorin, Inc.

K-Number K192064

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LPL 2019-10-02

OxySoft (olifilcon C) silicone hydrogel soft contact lens

Applicant Visco Vision, Inc.

K-Number K191397

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PLV 2019-10-02

Neocis Planning Software Application (NPSA) for 3rd Party PCs

Applicant Neocis, Inc.

K-Number K191363

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PTJ 2019-10-02

NG-Test CARBA 5

Applicant Ng Biotech

K-Number K191889

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