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 2016-04-26

Genesys Spine Apache Interbody Fusion System

Applicant Genesys Spine

K-Number K153123

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IYN 2016-04-26

Voluson P6, Voluson P8

Applicant GE Healthcare

K-Number K160162

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JCX 2016-04-25

Stryker Neptune 3 Waste Management System

Applicant Stryker Corporation

K-Number K153407

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DZE 2016-04-25

maxFit II Dental Implant System

Applicant Taiwan Implant Technology Company, Ltd.

K-Number K151588

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OAP 2016-04-25

Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202

Applicant Capillus, LLC

K-Number K160285

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LLZ 2016-04-25

MIM-Thin Client (mobile)

Applicant Mim Software, Inc.

K-Number K151913

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NBW 2016-04-25

POGO Automatic Blood Glucose Monitoring System

Applicant Intuity Medical, Inc.

K-Number K152493

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LIT 2016-04-25

MMS PTA Balloon Catheter

Applicant Micro Medical Solutions, Inc.

K-Number K152934

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NKB 2016-04-22

PASS LP Spinal System

Applicant Medicrea International SA

K-Number K153413

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HRS 2016-04-22

G3(TM) Active Plate(R) Small Fragment System

Applicant Genesis Fracture Care, Inc.

K-Number K160633

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MQG 2016-04-22

MIRI TL

Applicant At Medical Uab

K-Number K151357

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LLZ 2016-04-22

sterEOS Workstation

Applicant Eos Imaging, Inc.

K-Number K160914

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