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

GEI 2025-08-19

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

Applicant Venclose, Inc.

K-Number K252316

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QSM 2025-08-19

Remanufactured EndoWrist Cadiere Forceps (420049)

Applicant Rebotix

K-Number K250399

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QSM 2025-08-19

Remanufactured EndoWrist Tenaculum Forceps (420207)

Applicant Rebotix

K-Number K250539

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MAI 2025-08-19

OSSIOfiber® Interference Screw

Applicant OSSIO , Ltd.

K-Number K252022

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GEI 2025-08-19

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

Applicant Agnes Medical Co., Ltd.

K-Number K243713

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KGO 2025-08-19

Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

Applicant Harps Europe Manufacturing GmbH

K-Number K250313

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HRS 2025-08-18

ANTHEM® Fracture System

Applicant Globus Medical, Inc.

K-Number K251161

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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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