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

FRG 2016-11-18

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

Applicant Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti

K-Number K160595

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NKB 2016-11-18

Preference Elite Pedicle Screw System

Applicant Amedica Corporation

K-Number K162160

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DXN 2016-11-18

Fully Automatic Electronic Blood Pressure Monitor

Applicant Adon Health Co., Ltd.

K-Number K162230

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HRS 2016-11-18

EVOS Small Fragment Plating System

Applicant Smith & Nephew, Inc.

K-Number K162078

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MBI 2016-11-18

GFS Ultimate

Applicant Parcus Medical, LLC

K-Number K162198

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ECX 2016-11-18

Walk-O2-Bout

Applicant Essex Industries, Inc.

K-Number K161472

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DFH 2016-11-18

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator

Applicant Diazyme Laboratories

K-Number K153394

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GEX 2016-11-18

V30 system, V-Form Handpiece BC Medium applicator

Applicant Viora , Ltd.

K-Number K162363

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LNH 2016-11-18

MAGNETOM ESSENZA

Applicant Siemens Medical Solutions USA, Inc.

K-Number K161795

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DIO 2016-11-18

Quest Diagnostics HairCheck-DT (Cocaine)

Applicant Quest Diagnostics Incorporated

K-Number K152232

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LZA 2016-11-17

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color

Applicant Shen Wei (Usa), Inc.

K-Number K161074

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MAX 2016-11-17

Luna 3D Interbody Fusion System

Applicant Benvenue Medical, Inc.

K-Number K162431

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