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

EIH 2016-01-14

Rainbow LS Pressing

Applicant Genoss

K-Number K151846

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MLR 2016-01-13

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

Applicant Advanced Sterilization Products

K-Number K151725

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DQO 2016-01-13

IntraNovo Microcatheter

Applicant Texasmedical Technologies, Inc.

K-Number K153125

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NHA 2016-01-13

BioHorizons CAD/CAM Abutments

Applicant BioHorizons Implant Systems, Inc.

K-Number K151621

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OVD 2016-01-13

VerteLP Interbody Fusion Device

Applicant Vgi, LLC

K-Number K151312

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HTY 2016-01-13

IFS Fixation Scaffold System

Applicant Metric Medical Devices, Inc.

K-Number K152627

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PJA 2016-01-13

FFRct

Applicant HeartFlow, Inc.

K-Number K152733

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IYN 2016-01-13

S50 Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K152854

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MUI 2016-01-13

Sonishield 100 Antimicrobial Ultrasound Gel

Applicant Quotient Medical

K-Number K151070

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NRY 2016-01-13

Penumbra System ACE 64 and ACE 68 Reperfusion Catheters

Applicant Penumbra, Inc.

K-Number K152541

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PDQ 2016-01-13

NuVasiveNVM5 System

Applicant Nu Vasive, Incorporated

K-Number K152942

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JXI 2016-01-13

Nerve Capping Device

Applicant Polyganics Innovations BV

K-Number K152684

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