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

PNR 2020-09-28

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)

Applicant Jiangsu Shenli Medical Production Co., Ltd.

K-Number K200557

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OYE 2020-09-28

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit

Applicant Becton, Dickinson and Company

K-Number K201814

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QJP 2020-09-28

RIST Radial Access Catheter

Applicant Rist Neurovascular, Inc.

K-Number K201682

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NXC 2020-09-28

Eon Aligner

Applicant Eon Dental Jordan, LLC

K-Number K202685

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EBF 2020-09-28

Transcend

Applicant Ultradent Product, Inc.

K-Number K201795

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NAY 2020-09-28

da Vinci SP Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K192717

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GEI 2020-09-28

Electrosurgical Generator

Applicant New Deantronics Taiwan , Ltd.

K-Number K201221

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LON 2020-09-28

VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)

Applicant bioMerieux, Inc.

K-Number K193299

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DQX 2020-09-28

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

Applicant Volcano Corporation

K-Number K202543

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CAF 2020-09-27

Portable Mesh Nebulizer

Applicant Feellife Health, Inc.

K-Number K182906

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BZD 2020-09-25

Ventilator, Non-continuous (Respirator)

Applicant Respironics, Inc.

K-Number K201439

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KLE 2020-09-25

Light Cure Dental Adhesive

Applicant Rizhao Huge Biomaterials Company, Ltd.

K-Number K201787

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