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

PEH 2018-05-25

ClearGuard HD Antimicrobial Barrier Cap

Applicant Pursuit Vascular, Inc.

K-Number K180111

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JIL 2018-05-25

inui In-Home Urine Analysis Test System

Applicant Scanadu, Inc.

K-Number K180356

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FCX 2018-05-25

FUJIFILM Endoscopic CO2 Regulator GW-100

Applicant Fujifilm Corporation

K-Number K180711

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FKX 2018-05-24

Fresenius Liberty Select Cycler

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K181108

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JEY 2018-05-24

GBR system

Applicant Surgident

K-Number K170697

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QBS 2018-05-24

OsteoDetect

Applicant Imagen Technologies, Inc.

K-Number DEN180005

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LEL 2018-05-24

ActiGraph CentrePoint Insight Watch

Applicant Actigraph

K-Number K181077

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KNW 2018-05-24

Celling Aspiration Needle

Applicant Spine Smith Holdings, LLC

K-Number K180807

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KPR 2018-05-24

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85

Applicant Samsung Electronics Co., Ltd.

K-Number K180543

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FET 2018-05-24

EPX-4440FN Digital Video Processor with Light Source

Applicant Fujifilm New Development U.S.A., Inc.

K-Number K180414

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KNS 2018-05-24

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K-Number K172665

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OAS 2018-05-24

CS 9600

Applicant Trophy

K-Number K181136

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