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

DXH 2020-09-23

Halo AF Detection System

Applicant Livmor

K-Number K201208

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GZI 2020-09-23

Nerve and Muscle Stimulator

Applicant Shenzhen Xft Medical Limited

K-Number K193276

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MAX 2020-09-23

FlareHawk TiHawk9 Interbody Fusion System

Applicant Integrity Implants, Inc.

K-Number K201367

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MRC 2020-09-23

Boston One Step Liquid Enzymatic Cleaner

Applicant Bausch & Lomb, Incorporated

K-Number K200416

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DZE 2020-09-23

IBS Implant System

Applicant Innobiosurg Co., Ltd.

K-Number K202479

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HSB 2020-09-23

DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

Applicant Synthes (USA) Products, LLC

K-Number K201346

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HWC 2020-09-23

Responsive Arthroscopy Interference Screw System

Applicant Responsive Arthroscopy, LLC

K-Number K202569

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LZA 2020-09-22

Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs

Applicant O&M Halyard, Inc.

K-Number K200843

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FOZ 2020-09-22

BD Cathena Safety IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K201717

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MVN 2020-09-22

DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K202448

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KTT 2020-09-22

Accessories for the SixFix® Hexapod Fixator

Applicant Arrowhead De, LLC

K-Number K200123

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LNH 2020-09-22

Vantage Orian 1.5T, MRT-1550, V6.0

Applicant Canon Medical Systems Corporation

K-Number K202210

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