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

NUH 2016-05-20

CUR Model 1

Applicant Thimble Bioelectronics, Inc.

K-Number K160052

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DZE 2016-05-20

Microdent Ektos Implant System

Applicant Implants Microdent System S.L

K-Number K153650

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EIH 2016-05-20

IPS Style Ceram, IPS Style Ceram One, IPS Style Press

Applicant Ivoclar Vivadent, AG

K-Number K152103

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MAX 2016-05-19

Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System

Applicant Choicespine, LP

K-Number K153107

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LEJ 2016-05-19

Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200

Applicant Medtek Lighting Corp D/B/A Peacock Tanning

K-Number K152452

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KRD 2016-05-19

Nester Embolization Coils, Tornado Embolization Coils

Applicant Cook Incorporated

K-Number K153778

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GEH 2016-05-19

C2 CryoBalloon Focal Pear Catheter

Applicant C2 Therapeutics, Inc.

K-Number K160994

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OLO 2016-05-19

Navio

Applicant Blue Belt Technologies, Inc.

K-Number K160537

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JCT 2016-05-19

WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL

Applicant Boston Scientific Corporation

K-Number K152842

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HCG 2016-05-19

Target Detachable Coils

Applicant Stryker Neurovascular

K-Number K153658

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JWH 2016-05-19

EMPOWR PS Knee System

Applicant Encore Medical L.P.

K-Number K160342

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OCY 2016-05-19

EasyPass Guidewire

Applicant Medi-Globe Corporation

K-Number K153264

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