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

NUJ 2017-06-23

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K171324

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HIF 2017-06-23

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

Applicant Fisher & Paykel Healthcare

K-Number K162582

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GEX 2017-06-23

LASEMD Laser System

Applicant Lutronic Corporation

K-Number K171009

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FRO 2017-06-23

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

Applicant Ls Scientific Inc. D.B.A. Kse Scientific

K-Number K170270

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FMZ 2017-06-23

Babyleo TN500

Applicant Draegerwerk AG & CO Kgaa

K-Number K162821

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PVZ 2017-06-23

hypodermic Pinpoint GT Needle

Applicant C.R. Bard, Inc.

K-Number K163437

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OYE 2017-06-23

Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser

Applicant Beckman Coulter

K-Number K162897

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LLZ 2017-06-23

SUITESTENSA

Applicant Ebit Srl

K-Number K163668

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KTI 2017-06-23

CRE Pulmonary Balloon Dilatation Catheter

Applicant Boston Scientific Corporation

K-Number K170759

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MQV 2017-06-23

ReBOSSIS85

Applicant Orthorebirth Co., Ltd.

K-Number K170620

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LGD 2017-06-23

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

Applicant Roche Diagnostics

K-Number K162678

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DRG 2017-06-23

Ossler Exam Scope

Applicant Lr Med, Inc.

K-Number K171188

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