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

OOE 2017-08-25

Catalys Precision Laser System

Applicant Amo Manufacturing USA, LLC

K-Number K172002

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LZA 2017-08-25

Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)

Applicant Yty Industry (Manjung) Sdn Bhd

K-Number K171104

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MQB 2017-08-25

SKR 3000

Applicant Konica Minolta, Inc.

K-Number K171716

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LZA 2017-08-25

Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs

Applicant Shandong Feiyang Professional Gloves Co., Ltd.

K-Number K170136

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IMI 2017-08-25

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)

Applicant Brh Medical , Ltd.

K-Number K160378

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KXK 2017-08-25

Sirius MRI Marker NS

Applicant C4 Imaging, LLC

K-Number K171487

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LLZ 2017-08-25

VMA System version 3.0

Applicant Ortho Kinematics, Inc.

K-Number K172327

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MUU 2017-08-25

Revolve Envi 600 Advanced Adipose System

Applicant Lifecell Corporation

K-Number K163647

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FRO 2017-08-25

Hexagen Derm

Applicant Global Health Solutions, LLC

K-Number K171191

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DQX 2017-08-25

Hi-Torque Command 18 Guide Wire

Applicant Abbott Vascular

K-Number K172073

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NQQ 2017-08-25

OTIS Optical Coherence Tomography System

Applicant Perimeter Medical Imaging, Inc.

K-Number K171560

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EOB 2017-08-25

ShenDa Sinuscope

Applicant Shenyang Shenda Endoscope Co., Ltd.

K-Number K161298

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