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

MAX 2018-01-26

TiGer Shark System

Applicant Choicespine, LP

K-Number K172816

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LOX 2018-01-25

Gallant PTCA Dilatation Catheter

Applicant Medinol, Ltd.

K-Number K173581

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DQO 2018-01-25

Royal Flush Catheter

Applicant Cook Incorporated

K-Number K171264

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CBK 2018-01-25

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

Applicant Fisher and Paykel Healthcare Limited

K-Number K173060

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BSP 2018-01-25

EchoGlo Needle

Applicant Smiths Medical Asd, Inc.

K-Number K171968

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FXX 2018-01-25

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))

Applicant V&Q Manufacturing Corporation

K-Number K173062

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LLZ 2018-01-25

Arterys Oncology DL

Applicant Arterys, Inc.

K-Number K173542

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DQD 2018-01-25

CliniCloud Stethoscope

Applicant Stethocloud Pty.Ltd (Clinicloud)

K-Number K173448

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CJE 2018-01-25

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer

Applicant Lite-On Technology Corp. H.S.P.B.

K-Number K171971

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OKL 2018-01-25

ClearLine IV

Applicant Clearline MD

K-Number K171954

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HRX 2018-01-25

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)

Applicant Stryker Corporation

K-Number K172116

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OLR 2018-01-24

SUNTOUCH Dental Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K173196

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