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

QHA 2023-02-28

AccuICAS

Applicant ArteryFlow Technology Co., Ltd.

K-Number K221711

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NQQ 2023-02-28

SpectraWAVE Imaging System

Applicant Spectrawave, Inc.

K-Number K221257

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OCX 2023-02-27

Saneso Lens Wash Bottle Assembly (SAN-LWB-A)

Applicant Saneso, Inc.

K-Number K222173

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EIH 2023-02-27

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

Applicant Arum Dentistry Co., Ltd.

K-Number K223253

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QVI 2023-02-27

Ogmend® Implant Enhancement System

Applicant Woven Orthopedic Technologies

K-Number K223075

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HDX 2023-02-27

Milli Vaginal Dilator

Applicant Materna Medical

K-Number K220035

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PZJ 2023-02-27

Idylla MSI Test

Applicant Biocartis NV

K-Number K211181

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LPH 2023-02-27

BENCOX Mirabo Z Cup Cortinium

Applicant Corentec Co., Ltd.

K-Number K223223

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DQA 2023-02-26

Handheld Pulse Oximeter

Applicant Shenzhen Witleaf Medical Electronics Co., Ltd.

K-Number K213431

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FMF 2023-02-25

CompuFlo Epidural Computer Controlled Anesthesia System

Applicant Milestone Scientific, Inc.

K-Number K221702

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ODP 2023-02-24

Ti-Largo Cervical Interbody System

Applicant Flospine

K-Number K223231

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FMK 2023-02-24

babyLance Safety Heelstick (BLM, BLN, BLP)

Applicant Clinical Innovations, LLC

K-Number K223900

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