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

NEW 2016-11-23

Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,

Applicant Y. Jacobs Medical, Inc.

K-Number K160705

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NQX 2016-11-23

Xpert MRSA NxG

Applicant Cepheid

K-Number K162444

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GKT 2016-11-23

AMICUS Separator System, AMICUS Separator System; Refurbished

Applicant Fresenius Kabi USA,Llc

K-Number K162462

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HSB 2016-11-23

GAP ENDO-EXO MEDULLARY SYSTEM

Applicant Pega Medical, Inc.

K-Number K160545

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OWB 2016-11-23

Allura Xper R9

Applicant Philips Medical Systems Nethrlands BV

K-Number K162148

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HRS 2016-11-23

Biomet Microfixation SternaLock 360 Sternal Closure System

Applicant Biomet Microfixation

K-Number K163007

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MAX 2016-11-23

Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)

Applicant Choicespine, LP

K-Number K162103

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FRO 2016-11-23

PolyPlex Wound Dressing

Applicant Global Health Solutions, LLC

K-Number K160872

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DQA 2016-11-23

Masimo Disposable Transflectance Forehead Sensor

Applicant Masimo Corporation

K-Number K160940

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HRS 2016-11-23

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5

Applicant Aap Implantate AG

K-Number K161696

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EBW 2016-11-23

W&H Implantmed SI-1015 incl. Accessories

Applicant W&H Dentalwerk Burmoos GmbH

K-Number K161957

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LDF 2016-11-22

Pacel Flow Directed Pacing Catheter

Applicant St Jude Medical

K-Number K161873

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