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

NKB 2016-11-16

CD HORIZON® Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K162379

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LLZ 2016-11-16

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162541

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OHT 2016-11-16

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert

Applicant Cyden Limited

K-Number K162231

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EBF 2016-11-16

CAD/CAMouflage Milling Block

Applicant Prismatik Dentalcraft, Inc.

K-Number K162537

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IYN 2016-11-16

Aixplorer

Applicant Supersonic Imagine

K-Number K161999

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EMA 2016-11-16

DuoCem

Applicant Coltene/Whaledent AG

K-Number K160800

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MAX 2016-11-16

Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)

Applicant Evolution Spine, LLC

K-Number K160663

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GEX 2016-11-16

Diode Laser Therapy Machine

Applicant Beijing Adss Development Co., Ltd.

K-Number K161692

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EBF 2016-11-15

Charisma

Applicant Heraeus Kulzer, LLC (Mitsui Chemicals Group)

K-Number K160049

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CGX 2016-11-15

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K161494

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LLZ 2016-11-15

eUnity

Applicant Client Outlook, Inc.

K-Number K161515

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HRS 2016-11-15

VLP Wrist Fracture System

Applicant Smith & Nephew, Inc.

K-Number K161665

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