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

OHT 2023-03-28

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K

Applicant Shenzhen Fansizhe Science and Technology Co., Ltd.

K-Number K223928

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GEH 2023-03-28

ISOLIS Cryoprobe

Applicant Varian Medical Systems, Inc.

K-Number K230271

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MYN 2023-03-28

DTX Studio Clinic 3.0

Applicant Nobel Biocare AB

K-Number K221921

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NUJ 2023-03-28

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

Applicant Stryker Sustainability Solutions

K-Number K230251

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GAA 2023-03-28

CapnoSpot™ Pneumothorax Decompression Indicator

Applicant Pneumeric, Inc.

K-Number K223625

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NUC 2023-03-28

X-Y Lubricating Jelly

Applicant R&R Medical Corporation, Ltd.

K-Number K220226

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QFM 2023-03-28

Annalise Enterprise CXR Triage Trauma

Applicant Annalise-Ai Pty , Ltd.

K-Number K222179

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QIH 2023-03-28

RadioLens v1.0

Applicant Synapsica

K-Number K222174

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QFM 2023-03-28

Annalise Enterprise CXR Triage Trauma

Applicant Annalise-Ai Pty , Ltd.

K-Number K222268

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MED 2023-03-28

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

Applicant STERIS Corporation

K-Number K230582

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PBX 2023-03-28

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500

Applicant Capenergy Medical S.L.

K-Number K222260

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GEI 2023-03-28

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019

Applicant Stryker Sustainability Solutions

K-Number K230255

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