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

GZI 2017-02-03

RehaStim 2

Applicant Hasomed GmbH

K-Number K162683

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MHX 2017-02-03

Telemetry Transmitter

Applicant Edan Instruments, Inc.

K-Number K161056

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HRS 2017-02-03

AxSOS 3 Ti; Stryker Plating System

Applicant Stryker GmbH

K-Number K162439

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NFO 2017-02-03

Micro-current Wrinkle Reduction Facial service, model EP-400

Applicant Li-Tek Electronic Technology Corporation

K-Number K162106

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OOE 2017-02-03

LenSx Laser System

Applicant Alcon Laboratories, Inc.

K-Number K163551

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FTM 2017-02-03

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)

Applicant Curaseal, Inc.

K-Number K162388

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PQY 2017-02-03

ActiPatch(R)

Applicant Bioelectronics Corporation

K-Number K152432

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MOB 2017-02-03

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

Applicant Inova Diagnostics, Inc.

K-Number K161258

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DQY 2017-02-03

TrapLiner catheter

Applicant Vascular Solutions, Inc.

K-Number K161901

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EIH 2017-02-03

priti multidisc ZrO2 High Translucent

Applicant Pritidenta GmbH

K-Number K161025

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MVL 2017-02-03

GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord

Applicant Kerr Corporation

K-Number K162536

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DYB 2017-02-02

FlexCath Select Steerable Shealth and Dilator

Applicant Medtronic Cryocath, LP

K-Number K163268

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