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

NUC 2017-12-15

LifeStyles® SKYN® Intimate Moments Personal Lubricant

Applicant Sxwell USA, LLC

K-Number K172473

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MAX 2017-12-15

EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages

Applicant Eit Emerging Implant Technologies GmbH

K-Number K172888

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KFM 2017-12-15

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile

Applicant International Biophysics Corporation

K-Number K170029

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OWN 2017-12-15

Cellvizio 100 Series System with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K172844

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LQR 2017-12-15

Strange Bile Duct Stone Exploration Set

Applicant Cook Incorporated

K-Number K173687

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LTT 2017-12-15

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)

Applicant Beckman Coulter, Inc.

K-Number K172337

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FOZ 2017-12-15

BD Nexiva Diffusics Closed IV Catheter Systems

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K173354

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DPS 2017-12-15

ECG Acquisition Systems

Applicant Vales & Hills Biomedical Tech. , Ltd.

K-Number K163607

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DXN 2017-12-15

V10

Applicant Mediana Co., Ltd.

K-Number K170497

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OTO 2017-12-15

Polyform Synthetic Mesh

Applicant Boston Scientific Corporation

K-Number K171271

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NKG 2017-12-15

Proficient® Posterior Cervical Spine System

Applicant Spine Wave, Inc.

K-Number K172594

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DQA 2017-12-15

The Nellcor pulse oximetry monitor interface cable

Applicant Covidien

K-Number K172482

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