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

HSB 2021-02-17

FITBONE(R) TAA

Applicant Wittenstein Intens GmbH

K-Number K203399

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KGO 2021-02-17

Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K202401

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DXC 2021-02-17

VIOLA

Applicant Vascular Graft Solutions, Ltd.

K-Number K203307

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JWH 2021-02-17

iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System

Applicant Conformis, Inc.

K-Number K210252

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MBB 2021-02-17

SpaceFlex Shoulder

Applicant G21, S.R.L.

K-Number K202338

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JAK 2021-02-16

VesselIQ Xpress

Applicant GE Medical Systems SCS

K-Number K200626

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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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