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

IPL 2020-02-27

Explorer Mini

Applicant Permobil AB

K-Number K190682

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KNW 2020-02-27

APrioCore Plus

Applicant Apriomed AB

K-Number K193268

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NHA 2020-02-27

Rodo Abutment System

Applicant Rodo Medical, Inc.

K-Number K193274

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QJP 2020-02-27

AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter

Applicant Stryker Neurovascular

K-Number K200206

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DZE 2020-02-27

ST Internal Implant System

Applicant T-Plus Implant Tech. Co., Ltd.

K-Number K190919

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HRS 2020-02-27

Pitkar Locked Plating System

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K-Number K192619

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EOB 2020-02-27

Colibri Endoscopy System

Applicant 3nt Medical , Ltd.

K-Number K192305

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LZO 2020-02-27

Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

Applicant Biomet UK, Ltd.

K-Number K192683

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FBK 2020-02-27

Disposable Sclerotherapy Needle

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K190032

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JZO 2020-02-27

Elecsys Anti-TSHR

Applicant Roche Diagnostics

K-Number K193313

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GCA 2020-02-27

Fusion Quattro Extraction Balloon

Applicant Wilson-Cook Medical, Inc.

K-Number K200247

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HWC 2020-02-27

Omnia Medical Trauma Screws

Applicant Omnia Medical, LLC

K-Number K192096

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