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

NAY 2017-05-31

EndoWrist Stapler 45 System and Stapler 45 Reloads

Applicant Intuitive Surgical, Inc.

K-Number K171388

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DQY 2017-05-31

Reverse 021 Micro Catheter, Reverse 027 Micro Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K171268

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PRI 2017-05-31

B R A H M S PCT sensitive KRYPTOR

Applicant Brahms GmbH

K-Number K171338

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HJO 2017-05-31

SL 220

Applicant Carl Zeiss Meditec, AG

K-Number K162684

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JOW 2017-05-31

Lympha Press Optimal Plus

Applicant Mego Afek AC , Ltd.

K-Number K170658

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HWC 2017-05-31

ALLY(TM) Bone Screws

Applicant Providence Medical Technology, Inc.

K-Number K170698

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JWH 2017-05-31

Empowr CR Knee Tibial Insert

Applicant Encore Medical L.P.

K-Number K170573

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EBI 2017-05-31

Orthodontic Acrylic 2

Applicant Lang Dental Manufacturing Co., Inc.

K-Number K163482

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FPA 2017-05-31

Infusion Set for Single Use

Applicant Shinva Ande Healthcare Apparatus Co., Ltd.

K-Number K162601

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JWY 2017-05-31

Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)

Applicant bioMerieux, Inc.

K-Number K170670

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OCC 2017-05-30

FilmArray Respiratory Panel 2 (RP2)

Applicant Biofire Diagnostics, LLC

K-Number K170604

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DYB 2017-05-30

VenaCure EVLT NeverTouch Direct Introducer Sheath

Applicant AngioDynamics, Inc.

K-Number K170695

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