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

QIH 2023-09-22

qXR-CTR

Applicant Qure.Ai Technologies

K-Number K231149

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EFB 2023-09-22

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors

Applicant Foshan Coxo Medical Instrument Co., Ltd.

K-Number K220179

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NUV 2023-09-22

T-SHAPE 2

Applicant B&M S.R.L. Marketing Nel Benessere

K-Number K231092

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MQF 2023-09-22

FemaSeed Intratubal Insemination

Applicant Femasys, Inc.

K-Number K231730

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QJI 2023-09-22

iLet® Dosing Decision Software

Applicant Beta Bionics, Inc.

K-Number K232224

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KGO 2023-09-22

Single-Use Latex Sterile Surgical Gloves (SG100)

Applicant Fitone Latex Products Co., Ltd. Guangdong

K-Number K231446

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PEW 2023-09-22

UroLift 2 ATC Advanced Tissue Control System

Applicant Neotract, Inc.

K-Number K232558

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MRG 2023-09-22

ALFIS Vitamin D, ALFIS-3 Analyzer

Applicant Immunostics Inc.,

K-Number K221817

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LJS 2023-09-22

CATHTONG II PICC Catheter

Applicant L&Z Us, Inc.

K-Number K232594

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DHX 2023-09-22

Access CEA

Applicant Beckman Coulter, Inc.

K-Number K223921

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HQF 2023-09-22

VISULAS yag

Applicant Carl Zeiss Meditec, Inc.

K-Number K230350

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QAS 2023-09-22

Annalise Enterprise CTB Triage Trauma

Applicant Annalise-Ai Pty , Ltd.

K-Number K231384

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