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

LYZ 2017-06-27

Powder-Free Clear Vinyl Patient Examination Gloves

Applicant Zibo Yue Fan Medical Products Co, Ltd.

K-Number K170735

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LPH 2017-06-26

PROCOTYL® PRIME Acetabular Cup System

Applicant Microport Orthopedics, Inc.

K-Number K170444

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OKP 2017-06-26

SpringTMS

Applicant Eneura, Inc.

K-Number K162797

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MAX 2017-06-26

NuVasive® CoRoent® Thoracolumbar System

Applicant Nu Vasive, Incorporated

K-Number K170962

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NHI 2017-06-26

Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit

Applicant Spr Therapeutics, LLC

K-Number K170902

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DPS 2017-06-26

CardioLogs ECG Analysis Platform

Applicant Cardiologs Technologies

K-Number K170568

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NKB 2017-06-26

Swedge™ Pedicle Screw Fixation System

Applicant Spinal Resources, Inc.

K-Number K170045

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DJR 2017-06-26

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators

Applicant Lin-Zhi International, Inc.

K-Number K170416

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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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