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

HWC 2024-03-11

ARIX Cannulated Screw System

Applicant Jeil Medical Corporation

K-Number K233912

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QOF 2024-03-11

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)

Applicant Luminex Molecular Diagnostics, Inc.

K-Number K231758

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OLO 2024-03-11

OTS Hip

Applicant Ortoma AB

K-Number K232140

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ELC 2024-03-11

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG

Applicant Satelec - Acteon Group

K-Number K233922

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LFD 2024-03-11

Caphosol® Artifical Saliva (32 doses sachet box)

Applicant Eusa Pharma (Uk) Limited

K-Number K234015

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NHA 2024-03-09

Osteon Precision Milled Suprastructure

Applicant Implant Solutions Pty Ltd (Aka Osteon Medical)

K-Number K233083

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MQR 2024-03-08

WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System

Applicant Boston Scientific Corporation

K-Number K234046

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GWJ 2024-03-08

ALGO Pro Newborn Hearing Screener (ALGO Pro)

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K233649

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HJO 2024-03-08

HP-OCT (HP-OCT)

Applicant Cylite Pty. , Ltd.

K-Number K231760

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FBK 2024-03-08

Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)

Applicant Steris

K-Number K232826

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OHT 2024-03-08

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)

Applicant Shenzhen Mlay Intelligent Technology Co., , Ltd.

K-Number K240264

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HWC 2024-03-08

OSSIOfiber® Threaded Trimmable Fixation Nails

Applicant OSSIO , Ltd.

K-Number K233198

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