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

MUH 2017-07-06

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)

Applicant Villa Sistemi Medicali S.P.A.

K-Number K162190

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MAX 2017-07-06

Endoskeleton TO Interbody Fusion Device (IBD)

Applicant Titan Spine, LLC

K-Number K170399

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ONE 2017-07-06

Philips BlueControl

Applicant Philips Electronics Nederland B.V.

K-Number K171055

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GEH 2017-07-06

Dermal Cooling System

Applicant R2 Dermatology ,Inc

K-Number K171398

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DTC 2017-07-06

PSA Cable

Applicant Boston Scientific Corporation

K-Number K170815

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ONG 2017-07-06

CO2 Laser Therapy Systems

Applicant Beijing Sincoheren Science and Technology Development Co.

K-Number K162398

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KWQ 2017-07-06

Spider Cervical Plating System

Applicant X-Spine Systems, Inc.

K-Number K170224

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MUJ 2017-07-05

Eclipse Treatment Planning System

Applicant Varian Medical Systems, Inc.

K-Number K170969

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EBI 2017-07-05

TOKUYAMA CUREGRACE

Applicant Tokuyama Dental Corporation

K-Number K170549

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GWL 2017-07-05

g.Nautilus PRO

Applicant G.Tec Medical Engineering GmbH

K-Number K171669

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IZI 2017-07-05

Leica FL560

Applicant Leica Microsystems (Schweiz) AG

K-Number K170239

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OYE 2017-07-03

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK

Applicant Becton, Dickinson and Company

K-Number K170974

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