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

JAQ 2017-01-27

Advanced Gynecological Applicator

Applicant Nucletron B.V.

K-Number K161688

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DYB 2017-01-27

Vado Bi-Directional Steerable Sheath

Applicant Kalila Medical, Inc.

K-Number K162427

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DXT 2017-01-27

Ecomed Disposable Angiographic Syringes

Applicant Ecomed Solutions, LLC

K-Number K162088

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IRP 2017-01-27

RP Lite 760R

Applicant Mego Afek AC , Ltd.

K-Number K163280

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KRA 2017-01-27

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm

Applicant Callisyn Biomedical, Inc.

K-Number K161967

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LLZ 2017-01-27

nordicBrainEx

Applicant Nordicneurolab AS

K-Number K163324

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NXC 2017-01-27

3M Clear Tray Aligner

Applicant 3M Unitek Corporation

K-Number K163689

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LLZ 2017-01-27

EBM iDO Viewer 1.2.1

Applicant Ebm Technologies Incorporated

K-Number K162285

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LNH 2017-01-27

MAGNETOM Sempra with syngo MR E11S

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163211

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LNH 2017-01-27

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163312

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PQZ 2017-01-27

chromID Strepto B agar

Applicant bioMerieux, Inc.

K-Number K163042

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FAD 2017-01-27

Universa Firm Ureteral Stents and Stent Sets

Applicant Cook Incorporated

K-Number K161236

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