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

MOB 2018-03-23

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

Applicant Aesku.Diagnostics GmbH & Co. KG

K-Number K172461

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JSM 2018-03-23

UriSwab-Urine Collection, Transport and Preservation System

Applicant Copan Italia Spa

K-Number K180052

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FOZ 2018-03-23

SUPERCATH 5 (26G)

Applicant Togo Medikit Co., Ltd.

K-Number K172496

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LLZ 2018-03-23

MED-TAB

Applicant Plum Medical Solutions GmbH

K-Number K173241

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JWH 2018-03-23

Acculoc Total Knee System

Applicant Rootloc Co., Ltd.

K-Number K170753

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CAW 2018-03-23

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

Applicant Devilbiss Healthcare, LLC

K-Number K172648

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JAD 2018-03-23

SRT-100+

Applicant Sensus Healthcare, Inc.

K-Number K173425

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OWB 2018-03-23

ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR

Applicant Ecotron Co., Ltd.

K-Number K180473

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NBW 2018-03-23

Dario LC Blood Glucose Monitoring System

Applicant Labstyle Innovation, Ltd.

K-Number K172723

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LIX 2018-03-23

CPRmeter 2 CPR Feedback Device

Applicant Laerdal Medical AS

K-Number K173886

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GXN 2018-03-23

Longeviti PMMA Static Cranial Implant

Applicant Longeviti Neuro Solutions, LLC

K-Number K170410

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EOQ 2018-03-22

Monarch Endoscopy Platform (Monarch Platform)

Applicant Auris Surgical Robotics, Inc.

K-Number K173760

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