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

KTI 2017-09-21

PeriView FLEX

Applicant Olympus Surgical Technologies America

K-Number K171232

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IYE 2017-09-21

Zap-X Radiosurgery System

Applicant Zap Surgical Systems

K-Number K171804

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NAY 2017-09-21

IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories

Applicant Intuitive Surgical, Inc.

K-Number K170879

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IYN 2017-09-21

S60 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K172082

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LZA 2017-09-20

Powder Free Nitrile Examination Gloves (Orange)

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K171541

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HQD 2017-09-20

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

Applicant Art Optical Contact Lens, Inc.

K-Number K172314

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EZD 2017-09-20

Magic3 Go Intermittent Urinary Catheter

Applicant C.R. Bard, Inc.

K-Number K172247

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HIH 2017-09-20

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

Applicant Hologic, Inc.

K-Number K172566

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GCA 2017-09-20

Tri-Ex Extraction Balloon With Multiple Sizing

Applicant Wilson-Cook Medical, Inc.

K-Number K170292

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BTT 2017-09-20

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

Applicant Hamilton Medical AG

K-Number K163283

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FDT 2017-09-20

PENTAX Medical ED34-i10T, Video Duodenoscope

Applicant Pentax Medical

K-Number K163614

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OMP 2017-09-20

PICO Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical Limited

K-Number K172521

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