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

MQL 2018-10-23

Cumulus Remover

Applicant Kitazato Corporation

K-Number K182002

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DQA 2018-10-23

Masimo Rad-97 and Accessories

Applicant Masimo Corporation

K-Number K180046

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MBF 2018-10-23

Humeral Short Stem System

Applicant Shoulder Innovations, Inc.

K-Number K173824

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KNT 2018-10-23

Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port

Applicant Covidien

K-Number K180622

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CJY 2018-10-23

Randox Calcium (Ca)

Applicant Randox Laboratories, Ltd.

K-Number K182042

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LLZ 2018-10-23

JiveX

Applicant Visus Health IT GmbH

K-Number K181964

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NGX 2018-10-23

BTL 799-2T

Applicant BTL Industries, Inc.

K-Number K182106

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IYN 2018-10-23

Xperius Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K182529

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KPR 2018-10-23

GU60A, GU60A-65

Applicant Samsung Electronics Co., Ltd.

K-Number K182622

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JEC 2018-10-22

PIP Fix

Applicant Hand Biomechanics Lab, Inc.

K-Number K181192

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DRG 2018-10-22

Comarch e-Care Platform

Applicant Comarch Healthcare SA

K-Number K181248

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JAQ 2018-10-22

GM Implant Tubes, Length Cutting Gauge

Applicant Varian Medical Systems, Inc.

K-Number K172533

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