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

HIF 2017-03-02

ENDOFLATOR 40, ENDOFLATOR 50

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K161554

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JAK 2017-03-01

syngo. CT Neuro Perfusion

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163284

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IKN 2017-03-01

Cadwell Sierra Summit, Cadwell Sierra Ascent

Applicant Cadwell Industries, Inc.

K-Number K162383

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JWH 2017-03-01

EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

Applicant Microport Orthopedics, Inc.

K-Number K162026

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MQB 2017-03-01

DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS

Applicant Canon, Inc.

K-Number K170332

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GEI 2017-02-28

Jac-Cell Medic testers

Applicant Jac-Cell Medic

K-Number K170105

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OVD 2017-02-28

Biomet Fusion System

Applicant Zimmer Biomet Spine, Inc.

K-Number K163543

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JAQ 2017-02-28

Surface Applicator Set

Applicant Varian Medical Systems, Inc.

K-Number K162018

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NHA 2017-02-28

On1 Concept

Applicant Nobel Biocare AB

K-Number K161655

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CAF 2017-02-28

RTC 26-C Inline Aerosol Adapter

Applicant Instrumentation Industries, Inc.

K-Number K162753

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MTD 2017-02-28

FIRMap Catheter

Applicant Abbott Electrophysiology

K-Number K163709

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KNW 2017-02-28

Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set

Applicant Cook Incorporated

K-Number K170008

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