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

DWA 2020-03-06

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

Applicant Abbott (Formerly Thoratec Corporation)

K-Number K200306

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IYN 2020-03-06

EPIQ Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K200304

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PFW 2020-03-06

sam 2.0 Long Duration Ultrasound System

Applicant ZetrOZ Systems, LLC

K-Number K191568

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KGO 2020-03-06

SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V

Applicant Medline Industries, Inc.

K-Number K191915

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MXZ 2020-03-06

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).

Applicant Leica Biosystems Newcastle, Ltd.

K-Number K193393

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NKB 2020-03-06

LOSPA® IS Spinal Fixation System

Applicant Corentec Co., Ltd.

K-Number K200267

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GEI 2020-03-06

Plasma IQ

Applicant Neauvia North America, Inc.

K-Number K192813

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EOQ 2020-03-06

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

Applicant Olympus Medical Systems Corp.

K-Number K192164

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FTM 2020-03-06

VersaWrap Tendon Protector

Applicant Alafair Biosciences, Inc.

K-Number K200311

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JAA 2020-03-06

Insight Enhanced DRF Digital Imaging System

Applicant Imaging Engineering, LLC

K-Number K200396

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NKB 2020-03-06

MEGAFIX® Pedicle Screw Spinal System

Applicant Seohancare Co., Ltd.

K-Number K191655

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MNR 2020-03-06

NightOwl

Applicant Ectosense NV

K-Number K191031

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