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 2021-04-06

CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments

Applicant CarboFix Orthopedics , Ltd.

K-Number K210716

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DYB 2021-04-06

AcQCross Qx Integrated Transseptal Dilator/Needle

Applicant Acutus Medical, Inc.

K-Number K210685

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PQC 2021-04-06

MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)

Applicant Medacta International S.A.

K-Number K203673

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MBH 2021-04-06

Physica system

Applicant Lima Corporate S.P.A.

K-Number K210554

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DSY 2021-04-06

Vascutek Gelsoft Plus ERS Vascular Graft

Applicant Vascutek, Ltd.

K-Number K202703

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FXX 2021-04-06

Disposable Surgical Face Mask

Applicant Anhui Jiabao Protective Equipments Co., Ltd.

K-Number K203801

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NGX 2021-04-06

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

Applicant Arrive Systems, Inc.

K-Number K201257

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NKB 2021-04-06

Auxein Brand Vertaux 5.5 mm Pedicle Screw System

Applicant Auxein Medical Private Limited/71164

K-Number K201457

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DXC 2021-04-06

SiteSeal SV

Applicant Ensite Vascular

K-Number K210681

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DRE 2021-04-06

Endovascular Dilator and Sets

Applicant Cook Incorporated

K-Number K210734

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FXX 2021-04-05

Disposable Medical Mask

Applicant Dongguan Runlin Medical Supplies Technology Co., Ltd.

K-Number K202655

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LLZ 2021-04-05

ADAS 3D

Applicant Adas3D Medical S.L.

K-Number K210850

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