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

EZD 2023-05-22

PVC Hydrophilic Urethral Catheter

Applicant Well Lead Medical Co., Ltd.

K-Number K220722

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GEX 2023-05-22

HELIOS 785 Pico

Applicant Laseroptek Co., Ltd.

K-Number K230373

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LHI 2023-05-22

MixJect® Transfer Device

Applicant West Pharma. Services IL, Ltd.

K-Number K230464

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NUH 2023-05-22

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

Applicant Jiangxi Royall Smart Technology Co., Ltd.

K-Number K230443

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KLE 2023-05-22

Hi-Bond Universal

Applicant Mediclus Co., Ltd.

K-Number K230465

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GEX 2023-05-22

Laser Thermal Therapy Kit

Applicant Elesta S.P.A

K-Number K230460

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NXC 2023-05-22

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)

Applicant 3M Company, Unitek Orthodontic Products

K-Number K231464

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QJP 2023-05-22

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support

Applicant Imperative Care, Inc.

K-Number K231168

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LJE 2023-05-22

Introducer Needle

Applicant Youcare Technology Co.,Ltd. (Wuhan)

K-Number K222705

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JWH 2023-05-19

Klassic Knee Revision System

Applicant Total Joint Othopedics, Inc.

K-Number K230537

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QFG 2023-05-19

iLet® ACE Pump

Applicant Beta Bionics, Inc.

K-Number K223846

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LLZ 2023-05-19

Autoplaque

Applicant Cedars-Sinai Medical Center: Aim

K-Number K212758

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