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

FXX 2021-06-02

Surgical Face Mask

Applicant Rfx+Care Manufactoring Co., Ltd.

K-Number K203190

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FOZ 2021-06-02

BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System

Applicant Becton, Dickinson and Company

K-Number K200891

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MRD 2021-06-02

NATRELLE INSPIRA Single Use Sizers for Gel Implants

Applicant Allergan

K-Number K203229

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QMY 2021-06-02

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)

Applicant Mahana Therapeutics, Inc.

K-Number K211372

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HRS 2021-06-02

DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)

Applicant DePuy Synthes

K-Number K211051

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MAX 2021-06-02

SeaSpine WaveForm™ A Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K210583

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HWC 2021-06-01

Arthrex Beveled FT Screws

Applicant Arthrex, Inc.

K-Number K210994

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GXY 2021-06-01

Well-Life Garment Electrodes (GM Series)

Applicant Well-Life Healthcare Limited

K-Number K200942

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FED 2021-05-28

Pathfinder Endoscope Overtube

Applicant Neptune Medical, Inc.

K-Number K211301

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LPN 2021-05-28

ABT12 multi-purpose solution

Applicant Bausch & Lomb, Incorporated

K-Number K202932

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FBK 2021-05-28

Single Use Injection Needle

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K-Number K210917

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LPH 2021-05-28

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters

Applicant Waldemar Link GmbH & Co. KG

K-Number K200607

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