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

KOC 2017-12-14

CAREline Airless Hemodialysis Blood Tubing Sets

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K172238

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IYN 2017-12-14

E-CUBE 8

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K172732

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HTN 2017-12-14

Akros FibuLink Syndesmosis Repair Kit

Applicant Akros Medical

K-Number K173550

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NHA 2017-12-14

NobelPerfect Abutments

Applicant Nobel Biocare AB

K-Number K172854

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HTY 2017-12-14

WishBone K-Wire System

Applicant Wishbone Medical, Inc.

K-Number K173013

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ODP 2017-12-14

NuVasive® Modulus-C Interbody System

Applicant Nu Vasive, Incorporated

K-Number K172676

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OBP 2017-12-13

Neurosoft TMS (also CloudTMS)

Applicant Teleemg, LLC

K-Number K173441

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LIT 2017-12-13

Advocate PTA Catheter

Applicant Merit Medical Systems, Inc.

K-Number K173621

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NKB 2017-12-13

ANAX 5.5 Spinal System

Applicant U&I Corporation

K-Number K173524

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LPL 2017-12-13

Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

Applicant Tangible Science, LLC

K-Number K172692

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NBW 2017-12-13

NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K171480

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JDR 2017-12-13

Arthrex DynaNite Nitinol Staple

Applicant Arthrex, Inc.

K-Number K172052

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