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

CDD 2019-10-02

LIAISON Vitamin B12

Applicant DiaSorin, Inc.

K-Number K192064

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LPL 2019-10-02

OxySoft (olifilcon C) silicone hydrogel soft contact lens

Applicant Visco Vision, Inc.

K-Number K191397

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PLV 2019-10-02

Neocis Planning Software Application (NPSA) for 3rd Party PCs

Applicant Neocis, Inc.

K-Number K191363

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PTJ 2019-10-02

NG-Test CARBA 5

Applicant Ng Biotech

K-Number K191889

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IYN 2019-10-01

ExactVu High Resolution Micro-Ultrasound System

Applicant Exact Imaging, Inc.

K-Number K192303

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OLO 2019-10-01

Intellijoint® Navigation System

Applicant Intellijoint Surgical, Inc.

K-Number K191507

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KPR 2019-10-01

DIAMOND-5A/6A/8A

Applicant DRGEM Corporation

K-Number K192453

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LZO 2019-10-01

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System

Applicant Zimmer GmbH

K-Number K192416

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QIF 2019-10-01

Applied Biosystems Bacillus anthracis Detection Kit

Applicant Mriglobal

K-Number K183462

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HIH 2019-10-01

Aveta System

Applicant Meditrina, Inc.

K-Number K191958

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OCL 2019-10-01

Cardioblate CryoFlex Surgical Ablation System

Applicant Medtronic, Inc.

K-Number K191526

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LNH 2019-10-01

Signa Voyager, Signa Voyager Quantum

Applicant Ge Healthcare (Tianjin) Company Limited

K-Number K192426

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