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

JWH 2022-11-04

World Total Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K223062

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HWC 2022-11-04

Nextra CH Cannulated Hammertoe System

Applicant Nextremity Solutions, Inc.

K-Number K221610

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QJP 2022-11-04

BENCHMARK BMX81 Access System

Applicant Penumbra, Inc.

K-Number K221822

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DCK 2022-11-04

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

Applicant Procise Diagnostics

K-Number K201256

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GXY 2022-11-04

Self-adhesive Electrode

Applicant Guangdong Comytens Medical Technology Co., Ltd.

K-Number K222453

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MAI 2022-11-04

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL

Applicant Acuitive Technologies, Inc.

K-Number K220833

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QUJ 2022-11-04

CryoRobot Select System

Applicant Tmrw Life Sciences, Inc.

K-Number K221086

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ODP 2022-11-04

UniVy OsteoVy Cervical IBF System

Applicant Vy Spine, LLC

K-Number K221162

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IXI 2022-11-04

VHA Radiotherapy Bolus

Applicant Vha Dean

K-Number K222639

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QQU 2022-11-04

Luminopia One

Applicant Luminopia, Inc.

K-Number K221659

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FXX 2022-11-04

Disposable Medical Face Mask (DF3-001)

Applicant Wellmed Dental Medical Supply Co., Ltd.

K-Number K222697

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IRP 2022-11-04

Aquilo Sports CCT1500 System

Applicant Aquilo Sports, LLC

K-Number K223164

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