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

OAS 2020-04-09

PreXion3D Explorer EX

Applicant Prexion Corporation

K-Number K193329

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IYN 2020-04-09

MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K200001

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OAS 2020-04-09

hyperion X5, NewTom GO, X-RADiUS COMPACT

Applicant Cefla S.C.

K-Number K200688

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DSP 2020-04-09

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

Applicant Arrow International, Inc.

K-Number K200634

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ODP 2020-04-09

CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System

Applicant Orthofix, Inc.

K-Number K200052

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LZA 2020-04-09

Powder Free Nitrile Examination Glove (Aqua Green)

Applicant Riverstone Resources Sdn Bhd

K-Number K200326

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MUJ 2020-04-09

ClearCalc

Applicant Radformation, Inc.

K-Number K193640

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GWM 2020-04-09

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags

Applicant Medtronic, Inc.

K-Number K200630

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LLZ 2020-04-09

EchoNavigator

Applicant Philips Medical Systems Nederland B.V.

K-Number K200713

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DQA 2020-04-09

OxSAT 100

Applicant S.L.P. , Ltd.

K-Number K191574

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GCJ 2020-04-09

Standard Trocar

Applicant Standard Bariatrics

K-Number K200517

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CHL 2020-04-09

i-STAT CG4+ Cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K200492

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