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

FRO 2018-02-21

Catasyn Advanced Technology Wound Hydrogel

Applicant Synedgen, Inc.

K-Number K172338

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JXM 2018-02-21

DRI Benzodiazepine Assay

Applicant Microgenics Corporation

K-Number K173963

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DXN 2018-02-21

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579

Applicant Honsun (Nantong) Co., Ltd.

K-Number K170866

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MOI 2018-02-20

Elecsys CA 15-3 II

Applicant Roche Diagnostics

K-Number K171605

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LJS 2018-02-20

HydroPICC

Applicant Access Vascular, Inc.

K-Number K172885

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NKB 2018-02-20

SeaSpine NewPort Spinal System

Applicant SeaSpine Orthopedics Corporation

K-Number K180176

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IYN 2018-02-20

WS80A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K173513

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LZA 2018-02-20

U-MED Powder Free Polyethylene Examination Gloves,Blue Color

Applicant Jiangsu U-Med Rubber & Plastic Products Co., Ltd.

K-Number K173228

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GDW 2018-02-20

Tri-Staple 2.0 Reinforced Reload

Applicant Covidien

K-Number K173270

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DQE 2018-02-20

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)

Applicant Edwards Lifescience, LLC

K-Number K172423

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GCJ 2018-02-20

Aesculap Video Assisted Thoracic Surgery (VATS) INstruments

Applicant Aesculap, Inc.

K-Number K170683

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HCG 2018-02-18

Optima Coil System

Applicant Blockade Medical, LLC (D.B.A. Balt Usa)

K-Number K172390

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