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

MUH 2017-12-18

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

Applicant Kavo Dental Technologies, LLC

K-Number K172918

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EBF 2017-12-18

PEEK Biosolution

Applicant Merz Dental GmbH

K-Number K173124

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PHL 2017-12-17

HAL for Medical Use (Lower Limb Type)

Applicant Cyberdyne, Inc.

K-Number K171909

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DQX 2017-12-15

Raider Guidewire

Applicant Vascular Solutions, Inc.

K-Number K173532

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MSS 2017-12-15

pioli IOL Delivery System

Applicant Ast Products, Inc.

K-Number K172228

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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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