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

FMK 2023-02-10

Safety Lancet

Applicant Suzhou Zhenwu Medical Co., Ltd.

K-Number K223208

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FLE 2023-02-10

PRIMUS Healthcare Sterilizer (Model PSS11-HC)

Applicant Primus Sterilizer Company, LLC

K-Number K221474

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EIH 2023-02-10

Glass Ceramic

Applicant Shenzhen Xiangtong Co., Ltd.

K-Number K223194

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FDF 2023-02-10

DiLumen C1, EZ1 and Tool Mount

Applicant Lumendi, LLC

K-Number K221452

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KTT 2023-02-10

Orthex External Fixation System

Applicant OrthoPediatrics Corp.

K-Number K223786

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PDQ 2023-02-10

TELIGEN System Peripheral Motor Nerve Stimulation Indications

Applicant Medos International SARL

K-Number K223438

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OMP 2023-02-10

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large

Applicant Smith and Nephew Medical Limited

K-Number K213853

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HIR 2023-02-10

Perifit

Applicant X6 Innovations

K-Number K221476

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OVE 2023-02-09

CYGNUS-C Standalone ACIF System

Applicant GS Medical Co., Ltd.

K-Number K222041

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NKB 2023-02-09

G Surgical Marksman Spinal Deformity System

Applicant G Surgical, LLC

K-Number K230063

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FMF 2023-02-09

Insulin syringe with integrated needle DL

Applicant Dlp Medical Products, Corp.

K-Number K203211

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GEI 2023-02-09

ATTIVA

Applicant Italian Engineering S.R.L.

K-Number K220505

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