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

NAY 2017-01-19

da Vinci Xi Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K161178

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FLL 2017-01-19

Fever Scout™ Continuous Monitoring thermometer

Applicant VivaLNK, Inc.

K-Number K162137

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JGJ 2017-01-19

Atellica CH Magnesium (Mg)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K162399

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ILQ 2017-01-18

Noddle(TM)

Applicant Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.

K-Number K162817

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DRY 2017-01-18

Quantum Workstation

Applicant Spectrum Medical , Ltd.

K-Number K163657

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OUR 2017-01-18

Siconus SI Joint Fixation System

Applicant Camber Spine Technologies

K-Number K162121

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HQD 2017-01-18

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K163254

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HBG 2017-01-18

Taps for Resorbable Screws

Applicant Synthes (USA) Products, LLC

K-Number K153587

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DSA 2017-01-18

Multi-Link X2 ECG Cable and Lead Wire System

Applicant Carefusion 2200, Inc.

K-Number K162432

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GCJ 2017-01-18

EndoClot

Applicant Endoclot Plus Co., Ltd.

K-Number K162197

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PBF 2017-01-18

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides

Applicant Materialise NV

K-Number K163156

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BZD 2017-01-18

F&P Brevida™ Nasal Pillows Mask

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K161412

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