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

PMN 2016-05-10

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

Applicant Bio-Rad Laboratories

K-Number K152679

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MBI 2016-05-10

FiberTak DR

Applicant Arthrex, Inc.

K-Number K160319

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NLH 2016-05-10

Reprocessed Polaris X Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K160303

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NLH 2016-05-10

Reprocessed Livewire Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K160242

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KRO 2016-05-09

LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating

Applicant Waldemar Link GmbH & Co. KG

K-Number K152431

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DZE 2016-05-09

IBS Implant System

Applicant Innobiosurg Co., Ltd.

K-Number K153350

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GCJ 2016-05-09

True HD 3MOS Camera System

Applicant Conmed Corporation

K-Number K161017

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DRF 2016-05-06

Achieve ST Mapping Catheter, Catheter Connecting Cable

Applicant Medtronic, Inc.

K-Number K153139

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OBO 2016-05-06

Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor

Applicant Heidelberg Engineering GmbH

K-Number K152205

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FLL 2016-05-06

TD-1035 Thermometer

Applicant Taidoc Technology Corporation

K-Number K152680

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DXN 2016-05-06

Digital Blood Pressure Monitor

Applicant Suzhou Sunspirit Co., Ltd.

K-Number K152415

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GEI 2016-05-06

Monopolar single-use HF cable

Applicant Olympus Winter & Ibe GmbH

K-Number K160053

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