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

OLO 2026-04-16

Foundation Surgical Navigated Lateral Disc Prep Instruments

Applicant Foundation Surgical Group, Inc.

K-Number K260011

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HIF 2026-04-16

Insufflator (OPTO-IFL1000)

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K252318

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GXI 2026-04-16

Disposable Radiofrequency Cannula

Applicant ABBOTT MEDICAL

K-Number K253907

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NUC 2026-04-16

Julva Velvé Water-Based Personal Lubricant

Applicant Golden Isles Medical, Inc.

K-Number K254101

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FGE 2026-04-16

Endoflux Biliary & Pancreatic Stent Sets

Applicant Medi-Globe GmbH

K-Number K251658

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NKB 2026-04-16

ARx® SAI Implant System

Applicant Life Spine, Inc.

K-Number K254274

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ODP 2026-04-16

ORIO-3D Cage System

Applicant SpineCraft

K-Number K253260

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PCC 2026-04-16

Enso for Migraine

Applicant Hinge Health, Inc.

K-Number K254216

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DWJ 2026-04-16

Hot Pink Pad Warming System

Applicant Xodus Medical, Inc.

K-Number K260903

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EXQ 2026-04-16

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)

Applicant Bright Uro, Inc.

K-Number K253537

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QJP 2026-04-16

Next Generation 088 Catheter

Applicant Balt USA, LLC

K-Number K254223

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KTI 2026-04-16

ClearTip TBNA Type

Applicant Finemedix Co., Ltd.

K-Number K251478

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