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

LFL 2024-07-11

CUSA® Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K240493

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KGN 2024-07-11

Cytal® Wound Matrix; Cytal® Burn Matrix

Applicant Acell, Inc.

K-Number K241724

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JEY 2024-07-11

tmCMF Solution

Applicant Techmah Cmf

K-Number K233874

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IOR 2024-07-11

Manual Wheelchair

Applicant Lichtmega Technology Co., Ltd.

K-Number K241460

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PYT 2024-07-11

Natural Cycles

Applicant Natural Cycles Nordic AB

K-Number K241006

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GEI 2024-07-11

Sterile single use tip cleaner (WK800-S10 , WK800-S20)

Applicant Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd

K-Number K241022

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KGN 2024-07-11

MicroMatrix® UBM Particulate

Applicant Acell, Inc.

K-Number K241706

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LIT 2024-07-11

Oscar Peripheral Multifunctional Catheter system

Applicant Biotronik, Inc.

K-Number K241711

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QIH 2024-07-11

SubtleSYNTH (1.x)

Applicant Subtle Medical, Inc.

K-Number K241329

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LIT 2024-07-10

Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314

Applicant Boston Scientific Corporation

K-Number K241683

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QQX 2024-07-10

Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit

Applicant Life Technologies Corporation

K-Number K233453

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OHT 2024-07-10

IPL Hair Removal Device (YT01,YT02,YT03,YT04)

Applicant Shenzhen Jianrong Biomedical Electronics Co., Ltd.

K-Number K240016

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