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

HRS 2024-11-14

Tandry Q-Locking Plate System

Applicant Microware Precision Co., Ltd.

K-Number K242814

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POK 2024-11-14

Fetal EchoScan

Applicant Brightheart

K-Number K242342

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IRP 2024-11-14

Xrecovery (XR-001)

Applicant Shenzhen Xinrun Electric Appliances Co, Ltd.

K-Number K242940

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HRS 2024-11-14

Proximal Humerus Fixation System

Applicant Skeletal Dynamics, Inc.

K-Number K242436

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GEX 2024-11-14

Veincare

Applicant Wontech Co., Ltd.

K-Number K241930

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HRS 2024-11-14

Arthrex Elbow Fracture Plating System

Applicant Arthrex, Inc.

K-Number K242079

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ONF 2024-11-14

Intense Pulsed Light Treatment System (LK-PT)

Applicant Nanjing Bestview Laser S&T Co., Ltd.

K-Number K242440

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CBK 2024-11-13

RESPOND(R) Ventilator

Applicant Corvent Medical, Inc.

K-Number K241135

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EIH 2024-11-13

Dental Glass Ceramics Blocks (HT, LT, MT)

Applicant Hunan Vsmile Biotechnology Co., Ltd.

K-Number K242407

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OLK 2024-11-13

Nonin OTC Pulse Oximeter Model 3250

Applicant Nonin Medical, Inc.

K-Number K211498

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EFB 2024-11-13

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

Applicant Guangdong Jinme Medical Technology Co., Ltd.

K-Number K240337

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NKB 2024-11-13

MediRod Pedicle Screw System

Applicant Cmf Medicon Surgical, Inc.

K-Number K242764

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