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

KPI 2025-03-27

Levina Pelvic Floor Muscle Stimulator (RS-48)

Applicant Zmi Electronics , Ltd.

K-Number K241862

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QIH 2025-03-27

Salix Central

Applicant Artrya Limited

K-Number K243038

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GAT 2025-03-27

HyperSuture White/Green Extension Line

Applicant Threadstone, LLC

K-Number K242201

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DQY 2025-03-27

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)

Applicant Medtronic, Inc.

K-Number K250558

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QOG 2025-03-27

MallyaD injection pen adapter (MallyaD)

Applicant Biocorp Production

K-Number K250555

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QPL 2025-03-27

StarFormer (M008-3T)

Applicant Fotona D.O.O.

K-Number K241785

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OEB 2025-03-27

V5med Lung AI

Applicant V5med, Inc.

K-Number K242919

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FGB 2025-03-27

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

Applicant Scivita Medical Technology Co., Ltd.

K-Number K243708

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PIW 2025-03-27

Nurochek-Pro System

Applicant Headsafe Mfg Pty, Ltd.

K-Number K243426

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NKB 2025-03-27

HC Biologics Osteopoint Spinal Fixation System

Applicant HC Biologics, LLC

K-Number K250092

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ITI 2025-03-26

Power Wheelchair (YH-E6011,YH-E6013A)

Applicant Ningbo Youhuan Automation Technology Co., Ltd.

K-Number K250134

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KNS 2025-03-26

SB Knife Jr2 (MD-47702 and MD-47702L)

Applicant Sb-Kawasumi Laboratories, Inc.

K-Number K241855

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