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

FWP 2020-12-23

Customized Contour Implant

Applicant Implantech Associates, Inc.

K-Number K200610

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QNC 2020-12-23

Helix Laboratory Platform

Applicant Helix Opco, LLC

K-Number DEN190035

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OWB 2020-12-23

ControlRad Select Model Z

Applicant Controlrad, Inc.

K-Number K202431

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OVD 2020-12-23

Omnia Medical TiBrid-SA

Applicant Omnia Medical, LLC

K-Number K203207

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NUC 2020-12-23

LUBi Water Based Personal Lubricant

Applicant Boya Biotechnology Co., Ltd.

K-Number K203257

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QNE 2020-12-23

EndoRotor Device

Applicant Interscope, Inc.

K-Number DEN200016

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FXX 2020-12-23

Medical Face mask

Applicant Jiangsu Province Jianerkang Medical Dressing Co., Ltd.

K-Number K202061

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JAK 2020-12-23

OmniTom Elite

Applicant Neurologica Corporation, A Subsidiary of Samsung Electronics

K-Number K202526

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KDI 2020-12-23

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Applicant Quanta Dialysis Technologies, Ltd.

K-Number K193670

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OLO 2020-12-23

CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System

Applicant Brainlab AG

K-Number K202320

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KPS 2020-12-23

Affinity

Applicant Hermes Medical Solutions AB

K-Number K202882

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MJN 2020-12-23

Bridge Occlusion Balloon

Applicant Spectranetics, Inc.

K-Number K203540

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