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

NKB 2021-07-12

Zavation Spinal System

Applicant Zavation Medical Products, LLC

K-Number K211113

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LZA 2021-07-12

Nitrile Examination Gloves

Applicant 5r Med Instruments (Chengdu) Co., Ltd.

K-Number K210776

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DTZ 2021-07-12

EOS PMP

Applicant Sorin Group Italia S.R.L.

K-Number K211495

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DSA 2021-07-12

Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables

Applicant Medtronic, Inc.

K-Number K203556

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PGY 2021-07-12

RadiForce RX370

Applicant Eizo Corporation

K-Number K211491

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FXX 2021-07-12

Disposable Medical Face Mask

Applicant Suzhou Bolisi Medical Technology Co., Ltd.

K-Number K210244

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QIH 2021-07-12

PowerLook Density Assessment V4.0

Applicant Icad, Inc.

K-Number K211506

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LZA 2021-07-12

Nitrile Patient Examination Glove

Applicant Jiangxi Zhonghong Pulin Medical Products Co., Ltd.

K-Number K210723

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LZA 2021-07-10

Medical Nitrile Examination Gloves (Power free, Blue)

Applicant Jiangxi Hongda Medical Equipment Group , Ltd.

K-Number K210578

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MQB 2021-07-09

PRIMO S

Applicant A.T.S. Applicazione Tecnologie Speciali S.R.L.

K-Number K211542

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LON 2021-07-09

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

Applicant bioMerieux, Inc.

K-Number K201675

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LOD 2021-07-09

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

Applicant Heraeus Medical GmbH

K-Number K210607

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