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

HAO 2022-09-07

Matreneu Percutaneous Balloon Compression Kit

Applicant Shenzhen Shineyard Medical Device Co. , Ltd.

K-Number K220920

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NKB 2022-09-07

Mariner RDX System

Applicant SeaSpine Orthopedics Corporation

K-Number K222110

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FMK 2022-09-07

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G

Applicant Owen Mumford, Ltd.

K-Number K222111

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QTW 2022-09-07

EyeCTester

Applicant Neuro-Eye Diagnostic Systems, LLC

K-Number K203594

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KRD 2022-09-07

Easi-Vue embolic microspheres System

Applicant Abk Biomedical, Inc.

K-Number K220567

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MUJ 2022-09-07

syngo.via RT Image Suite

Applicant Siemens Medical Solutions USA, Inc.

K-Number K220783

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HTY 2022-09-06

Hammertoe Truss System (HTS)

Applicant 4Web Medical, Inc.

K-Number K221283

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MCW 2022-09-06

ROTAPRO Rotational Atherectomy System

Applicant Boston Scientific Corporation

K-Number K220962

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DZE 2022-09-06

Neodent Implant System - GM Narrow Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K220251

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LNH 2022-09-06

LiverMultiScan v5 (LMSv5)

Applicant Perspectum

K-Number K213960

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FRN 2022-09-06

Spectrum IQ Infusion System with Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K-Number K222048

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DQX 2022-09-06

ASAHI Gladius Mongo18 PV ES

Applicant Asahi Intecc Co., Ltd.

K-Number K213868

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