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

DRA 2017-09-06

Steerable Guide Catheter

Applicant Abbott Vascular

K-Number K172394

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IYN 2017-09-06

Poseidon Ultrasound System

Applicant Butterfly Network, Inc.

K-Number K163510

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MSS 2017-09-06

MicroSTAAR Injector System Cartridges

Applicant STAAR Surgical Company

K-Number K172375

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NGX 2017-09-06

Katalyst Mark 1 Muscle Stimulation System

Applicant Katalyst, Inc.

K-Number K171035

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BZD 2017-09-05

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

Applicant Bmc Medical., Ltd.

K-Number K163464

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LRC 2017-09-05

Relieva SpinPlus Nav Balloon Sinuplasty System

Applicant Acclarent, Inc.

K-Number K171687

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HIG 2017-09-05

FluidSmart

Applicant Thermedx, LLC

K-Number K172048

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DBM 2017-09-05

QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls

Applicant Inova Diagnostics, Inc.

K-Number K163525

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HAW 2017-09-01

NaviENT

Applicant Claronav, Inc.

K-Number K163439

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FPA 2017-09-01

Carefusion NeutraClear Needle-free connector (EL-NC1000)

Applicant Cair Lgl

K-Number K171117

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GEX 2017-09-01

Epilaser

Applicant Epilady 2000, LLC

K-Number K170970

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GXN 2017-09-01

CustomizedBone Service

Applicant Fin-Ceramica Faenza S.P.A.

K-Number K171507

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