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

HRS 2025-07-10

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

Applicant TriMed, Inc.

K-Number K251945

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DPS 2025-07-10

ZBPro Diagnostic

Applicant Zbeats, Inc.

K-Number K243252

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OWB 2025-07-09

Cios Alpha; Cios Flow

Applicant Siemens Medical Solutions USA, Inc.

K-Number K251520

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LCD 2025-07-09

ARCHITECT iGentamicin

Applicant Abbott Laboratories

K-Number K243500

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GEX 2025-07-09

Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

Applicant Boston Scientific Corporation

K-Number K251759

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HAW 2025-07-09

EZ-FIDUCIALS

Applicant Phasor Health, LLC

K-Number K250505

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OUR 2025-07-09

panaSIa SI Fusion System

Applicant Wenzel Spine, Inc.

K-Number K250247

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DZE 2025-07-09

HEXIM Implant; Samwon General Abutments

Applicant P&A USA

K-Number K243731

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LZA 2025-07-09

Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)

Applicant Basic Medical Technology, Inc.

K-Number K250193

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SBF 2025-07-09

OptiVu Shoulder

Applicant Mr Surgical Solutions, LLC

K-Number K250108

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KRD 2025-07-09

HARBOR Occlusion Device

Applicant Nuvascular, Inc.

K-Number K250133

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MHX 2025-07-09

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K242562

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