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

FEQ 2019-08-01

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM

Applicant United States Endoscopy Group, Inc.

K-Number K191559

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HAW 2019-08-01

Leksell Vantage Stereotactic System

Applicant Elekta Instrument AB

K-Number K190887

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MRG 2019-08-01

MAGLUMI 2000 25-OH Vitamin D

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K-Number K191499

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NUH 2019-08-01

Mini TENS Therapy Device

Applicant Shenzhen Jumper Medical Equipment Co., Ltd.

K-Number K182871

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LLZ 2019-08-01

MREplus+ Software

Applicant Resoundant, Inc.

K-Number K183193

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JWH 2019-08-01

SurgTech GENOLL Total Knee System

Applicant Surgtech, Inc.

K-Number K191192

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HRS 2019-08-01

LOQTEQ VA Calcaneus Plate 3.5

Applicant Aap Implantate AG

K-Number K182818

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IYE 2019-08-01

ImagingRing System on Rails

Applicant Medphoton GmbH

K-Number K191267

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GAT 2019-07-31

DemeTECH DemeFORCE Nonabsorbable Surgical Suture

Applicant Demetech Corporation

K-Number K190777

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DHB 2019-07-31

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae

Applicant Hycor Biomedical

K-Number K191510

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QEA 2019-07-31

EyeBOX

Applicant Oculogica, Inc.

K-Number K191183

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MQV 2019-07-31

Inion BioRestore

Applicant Inion OY

K-Number K191764

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