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

MAX 2016-01-20

AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer

Applicant Stryker Corporation

K-Number K151726

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JAK 2016-01-20

Stroke VCAR

Applicant GE Medical Systems SCS

K-Number K152584

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MAV 2016-01-20

basixTOUCH40 Inflation Syringe

Applicant Merit Medical Systems, Inc.

K-Number K153672

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JAK 2016-01-20

CAS-One IR

Applicant Cascination AG

K-Number K152473

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ODP 2016-01-19

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device

Applicant Medtronic Sofamor Danek

K-Number K153373

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DHB 2016-01-19

Phadia Prime

Applicant Phadia AB

K-Number K151029

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DRS 2016-01-19

Flo Trac sensor, Volume View sensor

Applicant Edwards Lifesciences, LLC

K-Number K152980

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MBI 2016-01-19

MultiFIX S Ultra Knotless Fixation System

Applicant Arthocare Corporation

K-Number K153669

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FPA 2016-01-19

Hospira Extension Sets

Applicant Icu Medical, Inc.

K-Number K151969

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OAP 2016-01-19

Capillus202

Applicant Capillus, LLC

K-Number K153618

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NKB 2016-01-19

M.U.S.T. Pedicle Screw System

Applicant Medacta International

K-Number K153664

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HWC 2016-01-19

Epic Extremity Cannulated Screw System

Applicant Epic Extremity, LLC

K-Number K153333

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