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

QNQ 2021-02-16

PLPT LDV (Low Dead Volume) Sterile Syringe

Applicant Poonglim Pharmatech, Inc.

K-Number K210443

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LLZ 2021-02-16

Vitrea Software Package, VSTP-001A

Applicant Canon Medical Systems Corporation

K-Number K203312

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OUR 2021-02-16

ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System

Applicant Aegis Spine

K-Number K210035

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FXX 2021-02-16

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On

Applicant Dukal Corporation

K-Number K201732

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PCC 2021-02-16

Relivion

Applicant Neurolief , Ltd.

K-Number K203419

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OCC 2021-02-16

cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K210234

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PKC 2021-02-16

Easytech® Anatomical Shoulder System

Applicant Fx Shoulder USA, Inc.

K-Number K201391

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DYB 2021-02-16

Extra Large Check-Flo Introducer

Applicant Cook Incorporated

K-Number K203670

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KRA 2021-02-16

Rebar Micro Catheter

Applicant Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular

K-Number K210114

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QNS 2021-02-16

EZ-Injec LDV Sterile Safety Needle

Applicant Poonglim Pharmatech, Inc.

K-Number K210444

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MWI 2021-02-15

740 SafeSAT

Applicant Zoe Medical, Inc.

K-Number K200160

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NHA 2021-02-12

Straumann Variobase C

Applicant Institut Straumann AG

K-Number K192742

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