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

LNH 2018-06-12

SyMRI

Applicant Syntheticmr AB

K-Number K181093

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MMI 2018-06-12

Access hs Tnl

Applicant Beckman Coulter, Inc.

K-Number K172783

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FRN 2018-06-12

Perfusor® Space Syringe Infusion Pump System

Applicant B.Braun Medical, Inc.

K-Number K172831

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LZA 2018-06-12

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

Applicant Riverstone Resources Sdn Bhd

K-Number K180452

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BSP 2018-06-12

Portex NRFit Epidural Needles

Applicant Smiths Medical Asd, Inc.

K-Number K172823

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LRK 2018-06-12

ZQuiet

Applicant Sleeping Well, LLC

K-Number K180124

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OQI 2018-06-12

E-XPE Acetabular Components and U-Motion II Acetabular Cup

Applicant United Orthopedic Corporation

K-Number K172833

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LYZ 2018-06-12

Powder Free Vinyl Patient Examination Gloves (Yellow, White)

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K180260

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KPS 2018-06-12

HeartSee Cardiac P.E.T. Processing Software

Applicant Bracco Diagnostics, Inc.

K-Number K181343

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NRY 2018-06-11

SOFIA Plus Aspiration Catheter

Applicant MicroVention, Inc.

K-Number K173200

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HRX 2018-06-11

Endiscope, Endiscope Cervical

Applicant Elliquence, LLC

K-Number K180766

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DQY 2018-06-11

Phenom 27 Catheter

Applicant Cathera, Inc.

K-Number K180959

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