Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

KRR 2018-06-14

Patello-Femoral Wave (Kahuna) Arthroplasty System

Applicant Arthrosurface, Inc.

K-Number K181280

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MMI 2018-06-14

Access hsTnl

Applicant Beckman Coulter, Inc.

K-Number K172787

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LLZ 2018-06-14

EchoMD Automated Ejection Fraction Software

Applicant Bay Labs, Inc.

K-Number K173780

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KWY 2018-06-14

SurgTech Bipolar Head System

Applicant Surgtech, Inc.

K-Number K173455

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OVD 2018-06-14

S128 Anterior Lumbar Interbody Fusion (ALIF) System

Applicant Renovis Surgical Technologies, Inc.

K-Number K180502

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DRG 2018-06-14

LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)

Applicant Hmicro, Inc.

K-Number K172011

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MIA 2018-06-14

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

Applicant Smiths Medical Asd, Inc.

K-Number K172800

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EZD 2018-06-14

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter

Applicant Compactcath, Inc.

K-Number K180738

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JXG 2018-06-14

Smart External Drain (SED) System

Applicant Aqueduct Critical Care, Inc.

K-Number K181301

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GEX 2018-06-14

InMode Diolaze System

Applicant Inmode MD , Ltd.

K-Number K180719

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GMQ 2018-06-14

ASI Evolution

Applicant Arlington Scientific, Inc. (Asi)

K-Number K173376

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LNH 2018-06-14

MRIaudio PREM System

Applicant Mriaudio

K-Number K180100

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