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

QFM 2019-08-12

Critical Care Suite

Applicant Ge Medical Systems, LLC

K-Number K183182

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NKB 2019-08-12

Facilis™ Spinal System

Applicant Baui Biotech Co., Ltd.

K-Number K191494

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BSP 2019-08-12

Dr J Spinal and Epidural Needles

Applicant Dr. Japan Co., Ltd.

K-Number K183316

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NHA 2019-08-12

Blue Sky Bio Zygomatic Implant System

Applicant Blue Sky Bio, LLC

K-Number K190491

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HRS 2019-08-12

Arsenal Plating System

Applicant Trilliant Surgical

K-Number K191009

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OUR 2019-08-12

EVOL® -SI Joint Fusion System

Applicant Cutting Edge Spine, LLC

K-Number K190025

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DZL 2019-08-09

Bone Screw, Bone Tack

Applicant Osstem Implant Co., Ltd.

K-Number K182881

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IZL 2019-08-09

DR 100s

Applicant Agfa N.V.

K-Number K191884

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MQV 2019-08-09

Morpheus-C

Applicant Biogennix, LLC

K-Number K190371

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IYN 2019-08-09

Versana Active

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K191798

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DQY 2019-08-09

Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter

Applicant Vascular Solutions, LLC

K-Number K191560

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PQK 2019-08-09

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

Applicant Avenu Medical

K-Number K191114

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