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

FRO 2018-11-23

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)

Applicant Medcu Technologies , Ltd.

K-Number K180643

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IYE 2018-11-23

Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System

Applicant Accuray Incorporated

K-Number K182687

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PCG 2018-11-23

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

Applicant Kronus, Inc.

K-Number K180607

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MSX 2018-11-23

Digistat Smart Central

Applicant Ascom Ums Srl Unipersonale

K-Number K180430

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HWC 2018-11-23

HammerTechTM Fixation System

Applicant Fusion Orthopedics, LLC

K-Number K182684

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HQD 2018-11-23

Hyper GP (tisilfocon A) Daily Wear Contact Lens

Applicant Contamac, Ltd.

K-Number K182304

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OCC 2018-11-23

Accula RSV Test

Applicant Mesa Biotech, Inc.

K-Number K181443

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FAD 2018-11-23

Greene Renal Transplant Stent Set

Applicant Cook Incorporated

K-Number K180557

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HWC 2018-11-23

Responsive Arthroscopy Interference Screw System

Applicant Responsive Arthroscopy, LLC

K-Number K180573

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NHA 2018-11-23

A.B. Dental Devices Dental Implants System

Applicant A.B. Dental Device , Ltd.

K-Number K181381

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HJO 2018-11-22

Sunkingdom Slit Lamp

Applicant Chongqing Sunkingdom Medical Instrument Co., Ltd.

K-Number K182306

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NUH 2018-11-21

PlayMakar Sport Muscle Stimulator, Model PRO-500

Applicant Playmakar, Inc.

K-Number K182581

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