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

DQA 2022-02-11

Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K211400

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NHN 2022-02-11

PainTB, PainTJ

Applicant Ptech Co., Ltd.

K-Number K203337

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HRS 2022-02-11

FlexitSystem Knee osteotomy system

Applicant Neosteo

K-Number K212545

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IYN 2022-02-11

ArtUs

Applicant Telemed

K-Number K211248

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ELW 2022-02-11

IMICRYL Impression Materials

Applicant Imicryl Dis Malzemeleri San. VE Tic. A.S.

K-Number K213890

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KWQ 2022-02-11

3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System

Applicant Orthofix US, LLC

K-Number K211712

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MSX 2022-02-11

Zyter RPM

Applicant Zyter, Inc.

K-Number K212622

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HGX 2022-02-11

Electric Breast Pump

Applicant Shantou Huihengqi Electronic Technology Co., Ltd.

K-Number K211024

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HSB 2022-02-11

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

Applicant Stryker GmbH

K-Number K213328

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FOZ 2022-02-11

B. Braun Introcan Safety 2 IV Catheter

Applicant B.Braun Medical, Inc.

K-Number K213664

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IZL 2022-02-11

EzRay M18 (Model: VMX-P400)

Applicant VATECH Co., Ltd.

K-Number K213462

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FDF 2022-02-10

Pure-Vu EVS System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K220007

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