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

FRN 2024-10-03

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets

Applicant Zevex, Inc.

K-Number K242660

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PLC 2024-10-03

Rest Assure System

Applicant Somnomed, Inc.

K-Number K233497

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ELL 2024-10-03

Additive Manufacturing Zirconia Customized Restoration

Applicant Hangzhou Thales Medtech Co., Ltd.

K-Number K240586

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DQA 2024-10-03

Pulse Oximeter (WS20A)

Applicant Hunan Accurate Bio-Medical Technology Co., Ltd.

K-Number K240808

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MEH 2024-10-03

Icona Hip Stem

Applicant Corin U.S.A. Limited

K-Number K241472

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ONN 2024-10-03

Lantern® Hip

Applicant Orthalign, Inc.

K-Number K242616

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KRD 2024-10-03

OBSIDIO™ Conformable Embolic

Applicant Boston Scientific

K-Number K242507

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KIF 2024-10-03

Injectable Root Canal Bioceramic Sealer (i-MTA SP)

Applicant Longly Biotechnology (Wuhan) Co., Ltd.

K-Number K241977

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JWH 2024-10-02

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component

Applicant Osteoremedies, LLC

K-Number K242377

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LNH 2024-10-02

VitruvianScan (v1.0)

Applicant Perspectum, Ltd.

K-Number K241925

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QJP 2024-10-02

8F Modified Sheath System

Applicant Route 92 Medical, Inc.

K-Number K240529

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MAX 2024-10-02

ARTFX Lumbar PEEK Cages

Applicant Artfx Medical

K-Number K240889

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