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

LZO 2025-05-23

RECLAIM Monobloc Revision Femoral Stem

Applicant Depuy Ireland UC

K-Number K251292

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QJP 2025-05-23

93 NeuFlex Catheter

Applicant Piraeus Medical

K-Number K251044

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OLX 2025-05-23

NeuroMatch

Applicant LVIS Corporation

K-Number K250239

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OHT 2025-05-23

Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K250938

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NFO 2025-05-23

SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1

Applicant Geske Beauty Tech GmbH

K-Number K250361

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OBJ 2025-05-23

ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach

Applicant ABBOTT MEDICAL

K-Number K251211

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BZD 2025-05-23

WiZARD 520 Full Face Mask

Applicant Wellell, Inc.

K-Number K243023

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JKA 2025-05-23

Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)

Applicant Venocare, Inc.

K-Number K244047

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QIH 2025-05-23

Second Opinion® 3D

Applicant Pearl, Inc.

K-Number K243989

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HAW 2025-05-23

Stereotaxic Guiding Surgical Devices, NaoTrac S

Applicant Brain Navi Biotechnology Co., Ltd.

K-Number K242575

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MQV 2025-05-23

MagnetOs MIS

Applicant Kuros Biosciences B.V

K-Number K243474

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IYN 2025-05-23

DEEPECHO

Applicant Deepecho

K-Number K242594

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