Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

LLZ 2020-02-18

Ashvins

Applicant Medicalcommunications GmbH

K-Number K200132

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MQB 2020-02-18

Vita Flex CR System with LLI

Applicant Carestream Health, Inc.

K-Number K192894

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MAX 2020-02-18

MOJAVE Expandable Interbody System

Applicant K2m, Inc.

K-Number K193203

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LBH 2020-02-18

DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor

Applicant Scientific Pharmaceuticals

K-Number K192381

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NDC 2020-02-18

InPen Dose Calculator

Applicant Companion Medical, Inc.

K-Number K190487

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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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