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

JSM 2024-04-25

Copan Universal Transport Medium (UTM-RT) System

Applicant Copan Italia Spa

K-Number K232357

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OCV 2024-04-25

ENDOFIX EXO

Applicant Aktormed GmbH

K-Number K232405

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NEW 2024-04-25

1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K232246

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DRY 2024-04-25

CDI OneView Monitoring System

Applicant Terumo Cardiovascular Systems Corporation

K-Number K234065

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MWI 2024-04-25

Portrait VSM

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K233810

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QIH 2024-04-25

InVision Precision LVEF (LVEF)

Applicant InVision Medical Technology Corporation

K-Number K232331

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NKB 2024-04-25

CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement

Applicant CarboFix Orthopedics , Ltd.

K-Number K240846

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KGN 2024-04-25

LUOFUCON® Collagen Particles (Collagen Wound Dressing)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K232796

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EBF 2024-04-25

Temporis, Irix Plus

Applicant Dws S.R.L.

K-Number K231142

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EFB 2024-04-25

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)

Applicant Nakanishi, Inc.

K-Number K233308

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HRX 2024-04-25

Digital ClarusScope System; Digital NeuroPEN System

Applicant Clarus Medical, LLC

K-Number K240535

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OAS 2024-04-25

Dental Cone-beam Computed Tomography

Applicant Yian Medical Technology (Haining) Co., Ltd.

K-Number K240855

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