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

MAX 2018-12-10

Lucent® XP

Applicant Spinal Elements, Inc.

K-Number K182584

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NKB 2018-12-10

Mega Plus Spine System

Applicant Bk Meditech, Co., Ltd.

K-Number K183080

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CAC 2018-12-10

CATSmart

Applicant Fresenius Kabi AG

K-Number K180831

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HKY 2018-12-10

Applanation tonometer AT-2

Applicant Takagi Seiko Co., Ltd.

K-Number K182491

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MOS 2018-12-07

Contour 24

Applicant Quality Electrodynamics, LLC

K-Number K183111

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MQB 2018-12-07

Nexus DR Digital X-ray Imaging System with stitching

Applicant Varex Imaging Corporation

K-Number K183212

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KPR 2018-12-07

GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A

Applicant Samsung Electronics Co., Ltd.

K-Number K182183

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MYA 2018-12-07

Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra

Applicant Leica Biosystems Newcastle, Limited

K-Number K183100

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DQY 2018-12-07

Tractus Crossing Support Catheter

Applicant Tractus Vascular, LLC

K-Number K180889

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NUH 2018-12-07

Neck Care Therapy, Model: SYK 509B

Applicant Shenzhen Osto Technology Co., Ltd.

K-Number K172897

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KOA 2018-12-07

FiXcision

Applicant Agency For Medical Innovations GmbH

K-Number K182664

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LZO 2018-12-07

Avenir Complete Hip System

Applicant Zimmer, Inc.

K-Number K182048

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