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

PNR 2016-09-01

Monoject Enteral Syringe with ENFit Connector

Applicant Covidien

K-Number K161963

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JPA 2016-09-01

Sysmex Automated Blood Coagulation Analyzer CS-2100i

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K161312

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LRK 2016-09-01

Noiselezz

Applicant Firma Ingemarsson

K-Number K160531

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ONF 2016-09-01

DUO

Applicant Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd

K-Number K161565

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MQB 2016-09-01

PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

Applicant Perkinelmer, Inc.

K-Number K161942

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FRN 2016-09-01

Concert Medical Hands-Free Syringe (HFS)

Applicant Concert Medical, LLC

K-Number K153599

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LZA 2016-09-01

EMG Pink Nitrile Examination Glove Powder Free

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K161320

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EOQ 2016-09-01

Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor

Applicant Ambu A/S

K-Number K161656

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LEJ 2016-09-01

IBL 5000 Tanning Booth

Applicant Ibl Acquisitions, LLC

K-Number K152405

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ETY 2016-09-01

Madsen Zodiac

Applicant Gn Otometrics

K-Number K161707

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GKZ 2016-09-01

BC-5390 Auto Hematology Analyzer

Applicant Mindray Bio-Medical Electronics Co., Ltd.

K-Number K160429

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HGX 2016-09-01

Hi bebe plus

Applicant Bistos Co., Ltd.

K-Number K160274

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