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

HIF 2020-10-21

EVA15

Applicant Palliare , Ltd.

K-Number K202799

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LHI 2020-10-21

Vial2Bag Advanced 20mm Admixture Device

Applicant West Pharmaceutical Services Az, Inc.

K-Number K201415

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IRP 2020-10-21

Powerpress Recovery Unit

Applicant Hanuri Distribution, Inc.

K-Number K202044

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MQV 2020-10-21

PRO-DENSE LoVisc Bone Graft Substitute

Applicant Wrightmedicaltechnologyinc

K-Number K200507

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GEI 2020-10-21

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm

Applicant Microline Surgical, Inc.

K-Number K201884

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KPR 2020-10-21

YSIO X.pree

Applicant Siemens Medical Solutions USA, Inc.

K-Number K201670

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OVE 2020-10-20

Hexanium® ACIF

Applicant Spinevision, S.A.S.

K-Number K193000

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NKB 2020-10-20

AccelFix Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K200794

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DZE 2020-10-20

MS Lide Implant Systems

Applicant Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd.

K-Number K181477

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LPL 2020-10-20

Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)

Applicant CooperVision, Inc.

K-Number K202756

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NDN 2020-10-20

SpineJack Expansion Kit

Applicant Stryker Corporation

K-Number K202393

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NEW 2020-10-20

WEGO-PDO Barbed Suture

Applicant Foosin Medical Supplies Inc., Ltd.

K-Number K201139

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