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

MAX 2023-03-29

Calibrate LTX Interbody System

Applicant Alphatec Spine, Inc.

K-Number K223611

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INI 2023-03-28

Electrical Scooter, WT-T4QP2

Applicant WuS Tech Co., Ltd.

K-Number K222729

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HRS 2023-03-28

KLS Martin Pure Pectus System

Applicant KLS Martin L.P.

K-Number K221938

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LNH 2023-03-28

MAGNETOM Amira; MAGNETOM Sempra

Applicant Siemens Medical Solutions USA, Inc.

K-Number K223343

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ODP 2023-03-28

SQUALE

Applicant Implanet, S.A.

K-Number K230026

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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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