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

CEW 2017-01-31

IDS-iSYS Intact PTHN

Applicant Immunodiagnostic Systems , Ltd.

K-Number K161158

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IYN 2017-01-31

Acclarix LX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K162055

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GEI 2017-01-31

OsteoCool V-3 RF Ablation System

Applicant Baylis Medical Company, Inc.

K-Number K161949

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JAA 2017-01-31

Philips CombiDiagnost R90

Applicant Philips Medical Systems Dmc GmbH

K-Number K163210

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DSP 2017-01-31

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case

Applicant Datascope Corp.

K-Number K163542

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DQX 2017-01-30

Radifocus Glidewire Advantage Track

Applicant Ashitaka Factory of Terumo Coporation

K-Number K163004

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MAX 2017-01-30

Elite Expandable Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K162879

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NHA 2017-01-30

ET Hybrid Abutment

Applicant Hiossen, Inc.

K-Number K162390

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ODG 2017-01-30

Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

Applicant Boston Scientific

K-Number K163058

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OLP 2017-01-30

LED Phototherapy Device

Applicant Li-Tek Electronic Technology Corporation

K-Number K162098

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GEI 2017-01-30

OBS Electrosurgical Generator (Model: OBS-350A)

Applicant Baisheng Medical Co., Ltd.

K-Number K162034

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GZI 2017-01-27

L300 Go System

Applicant Bioness, Inc.

K-Number K162407

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