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

KWQ 2023-07-19

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

Applicant L&K BIOMED Co., Ltd.

K-Number K231839

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QXG 2023-07-19

Galen ES Cooperative Surgical Assistant Platform, Galen ES

Applicant Galen Robotics

K-Number DEN220047

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FIP 2023-07-19

RenaPure Endotoxin Retentive Filter

Applicant Evoqua Water Technologies, LLC

K-Number K231410

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INI 2023-07-19

Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)

Applicant Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

K-Number K231472

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HRS 2023-07-19

TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System

Applicant Bonebridge AG

K-Number K231292

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LZY 2023-07-19

TANDEM Hip System

Applicant Smith & Nephew, Inc.

K-Number K231448

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OAS 2023-07-19

Grreen X 12 (Model: PHT-75CHS)

Applicant VATECH Co., Ltd.

K-Number K231796

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OEB 2023-07-19

syngo.CT Lung CAD (Version VD30)

Applicant Siemens Healthcare GmbH

K-Number K231157

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MRR 2023-07-19

AXINON® LDL-p Test System

Applicant Numares AG

K-Number K210801

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IRP 2023-07-19

LF900

Applicant Daesung Maref Co., Ltd.

K-Number K231437

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PBX 2023-07-19

BACK 3

Applicant Swims America Corp

K-Number K230037

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OLO 2023-07-18

Robotic Graft Delivery Instruments

Applicant Medtronic Sofamor Danek, Inc.

K-Number K230716

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