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

GCJ 2016-03-01

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm

Applicant Covidien

K-Number K160230

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BSO 2016-03-01

SPINAUT-E, SPINAUT-I

Applicant Imedicom Co., Ltd.

K-Number K150789

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LEJ 2016-03-01

3400E series; E5400 series; E6400 series; Sundazzler series

Applicant Heartland Tanning, Inc.

K-Number K151905

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LNH 2016-03-01

Wrist 3

Applicant Aspect Imaging, Ltd.

K-Number K160185

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FLL 2016-03-01

Braun Thermoscan PRO 6000 Ear Thermometer

Applicant Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)

K-Number K152748

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LLZ 2016-02-29

syngo.via MI Workflows

Applicant Siemens Medical Solutions USA, Inc.

K-Number K160317

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MQL 2016-02-29

BlastGen

Applicant Origio A/S

K-Number K152932

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HAE 2016-02-29

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs

Applicant K2 Medical GmbH & Co. KG

K-Number K150468

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OMP 2016-02-29

Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack

Applicant Kci USA, Inc.

K-Number K153199

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DHB 2016-02-29

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite

Applicant Phadia AB

K-Number K150597

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MHX 2016-02-26

Aingeal Activity System

Applicant Intelesens, Ltd.

K-Number K153275

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IYN 2016-02-26

LOGIQ S7 Expert

Applicant GE Healthcare

K-Number K160182

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