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

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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GEX 2017-12-13

2940 nm Er:Yag Laser Handpiece

Applicant Quanta System Spa

K-Number K173002

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PSZ 2017-12-13

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

Applicant Alere Scarborough, Inc.

K-Number K173502

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FED 2017-12-13

Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath

Applicant Cook Incorporated

K-Number K172217

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EIH 2017-12-13

Prodigio Stain Powder

Applicant Operart, LLC

K-Number K171167

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GXY 2017-12-13

Adhesive Electrodes

Applicant Shenzhen Quality Medical Technology Co.,Ltd

K-Number K171381

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