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

ORZ 2019-10-22

LipiFlow Thermal Pulsation System

Applicant Tearscience, Inc.

K-Number K192623

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FRC 2019-10-22

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

Applicant Sterilucent, Inc.

K-Number K192001

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NIG 2019-10-22

Lumpipulse G CA19-9-N

Applicant Fujirebio Dianostics, Inc.

K-Number K191973

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LXV 2019-10-22

ClearEdge Balance System

Applicant Quadrant Biosciences

K-Number K183661

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KWQ 2019-10-22

FORTICO Anterior Cervical Fixation System

Applicant Camber Spine Technologies, LLC

K-Number K191584

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HBL 2019-10-22

DORO QR3 XTom Headholder System

Applicant Pro Med Instruments GmbH

K-Number K191979

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FMG 2019-10-22

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

Applicant Monumedical, LLC

K-Number K190539

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PKL 2019-10-22

stentfix OTSC System Set

Applicant Ovesco Endoscopy AG

K-Number K183309

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LZG 2019-10-21

Omnipod Insulin Management System, Omnipod DASH Insulin Management System

Applicant Insulet Corporation

K-Number K192659

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MUD 2019-10-21

FORE-SIGHT ELITE Tissue Oximeter Module

Applicant Cas Medical Systems, Inc.

K-Number K190270

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FDT 2019-10-21

PENTAX Medical ED-3490TK Video Duodenoscope

Applicant Pentax Medical

K-Number K192280

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KWH 2019-10-21

Fusion Silastic System

Applicant Fusion Orthopedics, LLC

K-Number K190136

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