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

IYO 2020-10-07

AcuSee AS-P1000 System

Applicant Weipeng (Suzhou) Medical Devices Co., Ltd.

K-Number K202119

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MAI 2020-10-07

Citregen Tendon Interference Screw and Citrelock

Applicant Acuitive Technologies

K-Number K200725

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FLL 2020-10-07

Infrared Thermometer

Applicant Shenzhen Urion Technology Co., Ltd.

K-Number K200802

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FXX 2020-10-07

Livocare Surgical Mask

Applicant Andon Health Co, Ltd.

K-Number K201380

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MUH 2020-10-07

ScanX Edge

Applicant Dürr Dental SE

K-Number K202633

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KPR 2020-10-07

Radiographic System Challenge X

Applicant Sedecal., Sa.

K-Number K202293

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DYB 2020-10-06

iSleeve Introducer Set

Applicant Boston Scientific Corporation

K-Number K202584

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KTT 2020-10-06

Pitkar DeftFix System

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K-Number K200728

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KRH 2020-10-06

TruForm Sievers Annuloplasty Ring

Applicant Genesee Biomedical, Inc.

K-Number K202253

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MAX 2020-10-06

NuVasive® Cohere® Thoracolumbar Interbody System

Applicant Nu Vasive, Incorporated

K-Number K200953

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MBL 2020-10-06

R3 HA Coated Acetabular Shells

Applicant Smith & Nephew, Inc.

K-Number K201701

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GEI 2020-10-06

CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20

Applicant Bolder Surgical, LLC

K-Number K202114

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