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

HWC 2020-09-22

LTJ Screws and Washer

Applicant Azurmeds, Inc.

K-Number K200987

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IPF 2020-09-21

Medline DeNovo 4Pro Electrical Stimulation Device

Applicant Medline Industries, Inc.

K-Number K201290

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MEH 2020-09-21

World Hip Stem, World Cup, World Liner

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K201278

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QEW 2020-09-21

Pounce Thrombus Retrieval System

Applicant Surmodics,Inc.

K-Number K192814

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DXN 2020-09-21

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B

Applicant Bioland Technology, Ltd.

K-Number K201467

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KDI 2020-09-21

Optiflux F180NR Dialyzer

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K192707

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MUJ 2020-09-20

CORVUS

Applicant Best Nomos

K-Number K201350

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LLZ 2020-09-20

AAA Model

Applicant Philips Ultrasound, Inc.

K-Number K200603

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JOW 2020-09-19

B&J DVT Calf/Thigh Garments, Models 801/830 Series

Applicant B&J Manufacturing , Ltd.

K-Number K201532

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OUR 2020-09-18

Life Spine SIMPACT Sacroiliac Joint Fixation System

Applicant Life Spine, Inc.

K-Number K201538

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LZO 2020-09-18

SMS Cementless Stem

Applicant Medacta International S.A.

K-Number K201673

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KOC 2020-09-18

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K201207

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