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

MWI 2019-04-16

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

Applicant Andon Health Co, Ltd.

K-Number K181541

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NHA 2019-04-16

MIST IC

Applicant Imagine Milling Technologies, LLC

K-Number K182246

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EGS 2019-04-16

General Cutting Contra Handpiece

Applicant Nakanishi, Inc.

K-Number K182999

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KGE 2019-04-16

Avulsion Forceps

Applicant STERIS Corporation

K-Number K183428

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NLM 2019-04-15

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K182828

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JAK 2019-04-15

SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183548

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FAE 2019-04-15

Rigi10 Malleable Penile Prosthesis

Applicant Rigicon, Inc.

K-Number K181673

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GEX 2019-04-15

Diode Laser Treatment System

Applicant Weifang KM Electronics Co., Ltd.

K-Number K182924

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HIS 2019-04-15

One Touch

Applicant Thai Nippon Rubber Industry Public Company, Ltd.

K-Number K181844

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LLZ 2019-04-15

NDOHD High Definition Imaging System (NDOHD)

Applicant Altaravision, Inc.

K-Number K190420

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OAS 2019-04-15

PreXion3D Explorer

Applicant Prexion Corporation

K-Number K190320

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QAS 2019-04-15

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K190072

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