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

EIH 2021-07-01

MAZIC Claro CAD and MAZIC Claro Press

Applicant Vericom Co., Ltd.

K-Number K203672

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IYN 2021-07-01

DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K211337

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FAJ 2021-06-30

LUMINELLE DTx System

Applicant Uvision360, Inc.

K-Number K210512

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PNR 2021-06-30

Oral/Enteral Syringe with ENFit connector

Applicant Ningbo Tianyi Medical Appliance Co., Ltd.

K-Number K211025

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KIF 2021-06-30

Metapaste Plus

Applicant Meta Biomed Co., Ltd.

K-Number K210904

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DPS 2021-06-30

Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph

Applicant Philips Medical Systems

K-Number K210560

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MAX 2021-06-30

Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System

Applicant Spinal Elements, Inc.

K-Number K210044

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KRO 2021-06-30

LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE

Applicant Waldemar Link GmbH & Co. KG

K-Number K211768

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DWF 2021-06-30

Quantum Perfusion Arterial Cannula Graft

Applicant Qura S.R.L

K-Number K203057

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CCJ 2021-06-30

Pivot Breath Sensor

Applicant Carrot, Inc.

K-Number K201206

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MAX 2021-06-30

aprevo Transforaminal IBF

Applicant Carlsmed, Inc.

K-Number K210542

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HBE 2021-06-30

Stryker iBur hubs and cutting accessories

Applicant Stryker Corporation

K-Number K210377

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