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

LZO 2018-09-14

Prime E-CLASS XLPE Liner

Applicant Microport Orthopedics, Inc.

K-Number K181598

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JDQ 2018-09-14

Impress SFS System

Applicant Cable Fix Medical, LLC

K-Number K173910

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OHS 2018-09-14

POLY REJUV

Applicant Medtek Skincare, LLC

K-Number K180875

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GWN 2018-09-14

DizzyDoctor System 1.0.0

Applicant Dizzydoctor Systems, LLC

K-Number K182214

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OVD 2018-09-13

DYNA-LINK ELITE Stand-Alone Anterior Lumbar System

Applicant Life Spine, Inc.

K-Number K180215

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DQY 2018-09-13

SelectFlex 072 Neurovascular Access System

Applicant Q'Apel

K-Number K181000

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NKB 2018-09-13

MOSS VRS Spinal System

Applicant Biedermann Motech GmbH & Co. KG

K-Number K181821

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JWY 2018-09-13

MTS Penicillin 0.002- 32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K181889

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MQV 2018-09-13

Sorrento Bioglass Bone Graft Substitute

Applicant Xenco Medical, LLC

K-Number K173933

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OCX 2018-09-13

Seal Single Use Biopsy Valve

Applicant Boston Scientific Corporation

K-Number K182275

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OBO 2018-09-13

Spectralis HRA+OCT and variants with OCT Angiography Module

Applicant Heidelberg Engineering GmbH

K-Number K181594

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DZJ 2018-09-13

KLS Martin Individual Patient Solutions (IPS) Planning System

Applicant KLS-Martin L.P.

K-Number K181241

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