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

HIS 2025-02-21

Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)

Applicant Church & Dwight Co., Inc.

K-Number K243640

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LYC 2025-02-21

Synthetic Bone Graft Particulate

Applicant Shenzhen Dazhou Medical Technology Co., Ltd.

K-Number K241186

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EIH 2025-02-21

VITA YZ Multi Translucent

Applicant Vita Zahnfabrik H.Rauter GmbH & Co.

K-Number K243940

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EBG 2025-02-21

TEMP MASTER, PMMA-based dental resin

Applicant Taiwan Dental Materials Co., Ltd.

K-Number K243951

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NKB 2025-02-21

Primus Spinal Fixation System

Applicant Spinal Elements, Inc.

K-Number K243916

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HSB 2025-02-21

Fassier-Duval Telescoping IM System

Applicant Orthopediatrics Canada Ulc Dba Pega Medical

K-Number K241983

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OHS 2025-02-21

LYMA Laser PRO

Applicant Lyma Life , Ltd.

K-Number K243330

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QIH 2025-02-21

ScanDiags Ortho L-Spine MR-Q

Applicant Scandiags AG

K-Number K242607

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OAS 2025-02-21

Green X 12 SE (PHT-40CHS)

Applicant VATECH Co., Ltd.

K-Number K243088

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DXN 2025-02-21

Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))

Applicant Shenzhen Urion Technology Co., Ltd.

K-Number K243115

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NHA 2025-02-21

Custom Abutments

Applicant Institut Straumann AG

K-Number K243278

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MQV 2025-02-21

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC

Applicant Rti Surgical, Inc.

K-Number K241555

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