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

HTY 2016-09-16

Syntorr K-wire and Pin System

Applicant Syntorr, Inc.

K-Number K161489

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GEI 2016-09-16

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider

Applicant Covidien

K-Number K161804

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CAP 2016-09-16

VORTRAN Manometer

Applicant Vortran Medical Technology 1, Inc.

K-Number K153733

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OAP 2016-09-16

NutraStim Hair Laser Helmet

Applicant Nutra Luxe MD, LLC

K-Number K160728

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FMF 2016-09-16

Bone Solutions Mixing and Delivery System

Applicant Bone Solutions, Inc.

K-Number K161568

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GEX 2016-09-16

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

Applicant Ellipse A/S

K-Number K161162

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HRX 2016-09-16

mi-eye 2, mi-eye 2 monitor

Applicant Trice Medical

K-Number K162475

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DQK 2016-09-16

Sentry WEB SmartInterp

Applicant Carefusion Germany 234 GmbH

K-Number K153654

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LLZ 2016-09-16

JiveX

Applicant Visus Technology Transfer GmbH

K-Number K162008

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CAC 2016-09-16

CATSmart

Applicant Fresenius Kabi AG

K-Number K160735

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NHA 2016-09-16

Neodent Implant System - Titanium Base for CEREC

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K160964

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MOS 2016-09-16

TRILLIUM Oval Head Coil 32

Applicant Hitachi Medical Systems America, Inc.

K-Number K162079

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