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

NHA 2024-07-12

Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems

Applicant Prismatik Dentalcraft, Inc.

K-Number K240240

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KCT 2024-07-12

S.I.N. Instrument Kits

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K241378

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KDI 2024-07-12

HemoCare Hemodialysis System

Applicant Deka Research and Development

K-Number K233557

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QIH 2024-07-12

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Applicant Mighty Oak Medical

K-Number K234009

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JEY 2024-07-12

MRI Universal

Applicant Stryker Leibinger GmbH & Co KG

K-Number K240651

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QIH 2024-07-12

RUS

Applicant Hutom, Inc.

K-Number K233457

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DRE 2024-07-12

VersaCross Connect™ Transseptal Dilator

Applicant Baylis Medical Company, Inc.

K-Number K241720

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LPL 2024-07-12

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™

Applicant Unicon Optical Co., Ltd.

K-Number K241707

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MAX 2024-07-12

SPIRA® Anterior Lumbar Spacers

Applicant Camber Spine Technologies

K-Number K234077

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EIH 2024-07-12

Dental Glass Ceramics Blocks (HT,LT,ST)

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K241715

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QAS 2024-07-12

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K241727

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JWH 2024-07-11

ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;

Applicant Depuy Ireland UC

K-Number K241000

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