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

NUH 2019-04-26

Portable Electro-Stimulation Therapy Device

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K-Number K182108

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CIG 2019-04-26

VITROS XT Chemistry Products TBIL-ALKP Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K190807

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PEB 2019-04-26

JO Actively Trying Personal Lubricant

Applicant United Consortium

K-Number K182585

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MSX 2019-04-26

Philips IntelliVue XDS Software

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K182637

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KWS 2019-04-26

AltiVate Reverse Humeral Stem, 48mm

Applicant Encore Medical L.P.

K-Number K190290

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LLZ 2019-04-25

Brainlab Elements Image Fusion Angio

Applicant Brainlab AG

K-Number K190042

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LLZ 2019-04-25

Synapse Enterprise Viewer Version 1.0

Applicant Fujifilm Corporation

K-Number K183248

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HHT 2019-04-25

exCellerator Cervical Collection Device

Applicant Excell Company, LLC

K-Number K182049

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KPR 2019-04-25

MasteRad MX30

Applicant Medicatech USA

K-Number K190601

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KNW 2019-04-25

Ranfac Cartilage Biopsy Needle

Applicant Ranfac Corporation

K-Number K183146

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KRA 2019-04-25

Multi-Sideport Catheter Infusion Set

Applicant Cook Incorporated

K-Number K182071

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NQX 2019-04-25

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

Applicant Cepheid

K-Number K190771

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