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

KRD 2021-10-01

HRSpheres Narrow-Size Embolic Microspheres

Applicant Suzhou Hengrui Hongyuan Medical Co., Ltd.

K-Number K210562

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QQH 2021-10-01

iotaSOFT Insertion System - Drive Unit, Controller and Accessories

Applicant Iotamotion, Inc.

K-Number DEN190055

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DXN 2021-10-01

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

Applicant Edan Instruments, Inc.

K-Number K210139

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PNN 2021-10-01

BRIUS Planner Software

Applicant Brius Technologies, Inc.

K-Number K212828

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IYE 2021-10-01

Elekta Unity

Applicant Elekta Solutions AB

K-Number K212114

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IPF 2021-10-01

STELLA BIO

Applicant Egzotech Sp. Z O. O.

K-Number K210002

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OWB 2021-10-01

Zenition 70

Applicant Philips Medical Systems Nederland B.V.

K-Number K212813

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FET 2021-10-01

D Camera Controller

Applicant Richard Wolf Medical Instruments Corporation

K-Number K211332

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LPH 2021-10-01

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS

Applicant Microport Orthopedics, Inc.

K-Number K200011

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PCV 2021-10-01

PENTAX Medical Auto Leakage Tester SHA-P6

Applicant Pentax of America, Inc.

K-Number K212201

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GDW 2021-10-01

Surgimatix Absorbable Fixation System

Applicant Surgimatix, Inc.

K-Number K201934

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HIH 2021-10-01

Medical Endoscope Image Processing System

Applicant Jiangsu Jiyuan Medical Technology Co., Ltd.

K-Number K210270

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