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

OEB 2016-09-09

ClearRead CT

Applicant Riverain Technologies, LLC

K-Number K161201

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ITI 2016-09-09

Liberator Powered Wheelchair with Solar Companion

Applicant Solar Mobilityllc

K-Number K153636

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BZD 2016-09-09

S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV

Applicant Resmed, Ltd.

K-Number K160822

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GZT 2016-09-09

Self-retaining Retractor

Applicant Fetzer Medical GmbH & Co. KG

K-Number K161004

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FMF 2016-09-09

Sure-Fine Insulin Syringes

Applicant Shina Med Corporation

K-Number K152879

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KLE 2016-09-09

All-Bond Universal w/BAC (not finalized)

Applicant Bisco, Inc.

K-Number K161051

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JDQ 2016-09-09

Tritium® Sternal Cable Plate System

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K-Number K161876

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GEX 2016-09-09

Matrix LS-40 CO2 Laser System

Applicant Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

K-Number K161356

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MNS 2016-09-09

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

Applicant Resmed, Ltd.

K-Number K161487

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KPS 2016-09-08

Symbia 6.5

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162337

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PEK 2016-09-08

coflex-IF

Applicant Paradigm Spine, LLC

K-Number K153302

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PLV 2016-09-08

Navident

Applicant Claronav, Inc.

K-Number K161406

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