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

DRT 2024-05-30

The Circadia C200 System

Applicant Circadia Technologies, Ltd.

K-Number K234003

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GEI 2024-05-30

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

Applicant Zhejiang Curaway Medical Technology Co., Ltd.

K-Number K232505

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SAF 2024-05-29

Lingo Glucose System

Applicant Abbott

K-Number K233655

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PCH 2024-05-29

EasyScreen Gastrointestinal Parasite Detection Kit

Applicant Genetic Signatures Limited

K-Number K232672

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QJI 2024-05-29

SmartAdjust(TM) technology

Applicant Insulet Corporation

K-Number K232741

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PZR 2024-05-29

NET Recovery Corp/NET Device

Applicant Net Recovery

K-Number K233166

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MBI 2024-05-29

Arthrex TightRope II

Applicant Arthrex, Inc.

K-Number K241235

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KTT 2024-05-29

LINK(TM) External Fixator

Applicant Metric Medical Devices, Inc.

K-Number K240049

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QEW 2024-05-29

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)

Applicant Devoro Medical, Inc.

K-Number K241207

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NEY 2024-05-29

Temperature Sensor Probe (ABL-18TP20)

Applicant Varian Medical Systems, Inc.

K-Number K240784

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GEX 2024-05-29

InnoVoyce VYLO

Applicant Innovoyce

K-Number K240159

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QNQ 2024-05-29

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

Applicant Poonglim Pharmatech, Inc.

K-Number K241190

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