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

OLO 2025-08-18

Evolution Spine Navigation Instruments

Applicant Evolution Spine

K-Number K250167

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LZA 2025-08-18

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

Applicant O&M Halyard, Inc.

K-Number K243604

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OBP 2025-08-18

Apollo TMS Therapy System

Applicant Mag & More GmbH

K-Number K243539

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JOW 2025-08-18

PnueAira (PNCU-01)

Applicant Biotab, LLC

K-Number K251086

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DZE 2025-08-18

Neodent Implant System - Zirconia Implant System

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K250271

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HRS 2025-08-16

OsteoCentric® UnifiMI® TCS Plating System

Applicant OsteoCentric Technologies

K-Number K251913

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FIE 2025-08-15

JMS CAVEO A.V. Fistula Needle Set

Applicant JMS North America Corporation

K-Number K251877

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NFT 2025-08-15

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

Applicant Assure Tech., LLC

K-Number K252259

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GZJ 2025-08-15

CP Relief Wand Rx - TENS/NMES

Applicant N & C Holdings, LLC

K-Number K252236

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OHS 2025-08-15

FEATHER 01 02 03 04 (Model:01)

Applicant Heat IN A Click, LLC

K-Number K251871

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KPS 2025-08-15

PHAROS

Applicant Brightonix Imaging

K-Number K250170

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HRS 2025-08-15

KLS Martin Ixos System

Applicant KLS Martin L.P.

K-Number K250620

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