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

FMF 2020-02-18

Mixing and Delivery System

Applicant Bone Solutions, Inc.

K-Number K192674

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PSZ 2020-02-18

CareStart Flu A&B Plus

Applicant Access Bio, Inc.

K-Number K191514

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HRS 2020-02-16

APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System

Applicant Medartis AG

K-Number K193554

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DYG 2020-02-16

Swan-Ganz Catheters

Applicant Edwards Lifesciences, LLC

K-Number K193466

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KRD 2020-02-14

EMBA Hourglass Peripheral Embolization Device (PED)

Applicant Embolic Acceleration, LLC

K-Number K200083

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JOZ 2020-02-14

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01

Applicant Fujimori Kogyo, Co., Ltd.

K-Number K191364

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PGW 2020-02-14

TGS Universal Headrest with Mounting Arm

Applicant Stryker Ent

K-Number K193502

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BTR 2020-02-14

Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm, Venner PneuX ETT (Endotracheal Tube) 8 mm, Venner PneuX ETT (Endotracheal Tube) 9 mm

Applicant Venner Medical (Singapore) Pte, Ltd.

K-Number K192120

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LLZ 2020-02-14

ASCEND Image Viewer

Applicant Ascend Hit

K-Number K192372

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NEZ 2020-02-14

CapsoCam Plus (SV-3) Capsule Endoscopy System

Applicant CapsoVision, Inc.

K-Number K192662

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KPS 2020-02-14

CardIQ Flow

Applicant GE Medical Systems SCS

K-Number K192277

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MQB 2020-02-14

E-COM DR-2000 DR

Applicant Livermoretech, Inc.

K-Number K193644

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