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

KRA 2021-01-29

MAGIC Infusion Catheter

Applicant Balt USA, LLC

K-Number K202366

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HTY 2021-01-29

PediFlex Flexible Nail System

Applicant OrthoPediatrics Corp.

K-Number K201838

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QAU 2021-01-29

EndoClot

Applicant Endoclot Plus Co., Ltd.

K-Number K190677

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BTY 2021-01-28

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

Applicant Eresearchtechnology GmbH

K-Number K202754

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QJP 2021-01-28

BOSS 8F Balloon Guide Catheter

Applicant Marblehead Medical, LLC

K-Number K203840

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DWF 2021-01-28

Michler-Kapp Cardiovascular Vent Catheter

Applicant Kapp Surgical Instrument, Inc.

K-Number K200289

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MWI 2021-01-28

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s

Applicant Edan Instruments, Inc.

K-Number K202892

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HRS 2021-01-28

Biomet Microfixation RibFix Advantage System

Applicant Biomet Micofixation

K-Number K203474

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FRO 2021-01-28

LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K201016

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NKB 2021-01-28

Vitality® Spinal Fixation System

Applicant Zimmer Biomet Spine, Inc.

K-Number K203507

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KCT 2021-01-28

Standard Sterilizable Tray

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K202524

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OSF 2021-01-28

HipXpert 3D Display and Anchoring Application

Applicant Surgical Planning Associates, Inc.

K-Number K200384

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