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

MWI 2016-09-09

AMC Health VitalCaregiving System

Applicant Amc Health

K-Number K151839

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DQY 2016-09-09

TorqVue Low Profile Delivery Catheter

Applicant Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor

K-Number K162228

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GEI 2016-09-09

Enseal X1 Large Jaw Tissue Sealer

Applicant Ethicon Endo-Surgery, LLC

K-Number K160554

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HIS 2016-09-09

Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant

Applicant Church & Dwight Co., Inc.

K-Number K161915

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GEI 2016-09-09

Arthrex Synergy RF System

Applicant Arthrex, Inc.

K-Number K161581

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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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