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

HRS 2018-03-19

Anchorage Bone Plating System

Applicant Stryker GmbH

K-Number K172148

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NRY 2018-03-18

AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm

Applicant Stryker

K-Number K173841

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KGN 2018-03-16

XCelliStem Wound Powder

Applicant Stemsys

K-Number K172593

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KRH 2018-03-16

MEMO 4D

Applicant Sorin Group Italia S.R.L.

K-Number K180411

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NHA 2018-03-16

MIS CONNECT Conical Connection Abutment

Applicant Mis Implants Technologies , Ltd.

K-Number K173326

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HIF 2018-03-16

SurgiQuest AIRSEAL iFS System

Applicant Conmed Corporation

K-Number K172516

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DXN 2018-03-16

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Applicant Microlife Intellectual Property GmbH

K-Number K171937

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NJM 2018-03-16

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System

Applicant 3M Healthcare

K-Number K180404

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LSL 2018-03-16

Xpert CT/NG

Applicant Cepheid

K-Number K173840

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OUR 2018-03-16

SI Screw System

Applicant Zavation Medical Products, LLC

K-Number K173752

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MDB 2018-03-16

BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial

Applicant Becton, Dickinson and Company

K-Number K173873

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HQD 2018-03-16

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG

Applicant Paragon Vision Sciences

K-Number K180172

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