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

EYC 2020-10-15

Foley Catheter with Temperature Sensor

Applicant Deroyal Industries, Inc.

K-Number K200757

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FMI 2020-10-15

Droplet Pen Needle 30G & 33G

Applicant Htl-Strefa S.A

K-Number K202340

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HQC 2020-10-15

xPORT S Lens Fragmentation System

Applicant Carl Zeiss Meditec Cataract Technology, Inc.

K-Number K200207

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JWJ 2020-10-15

Arthrosurface WristMotion Total Wrist Arthroplasty System

Applicant Arthrosurface, Inc.

K-Number K200718

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LPL 2020-10-15

Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses

Applicant Pegavision Corporation

K-Number K200296

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HWC 2020-10-15

OsteoMed ExtremiFix Mini & Small Cannulated Screw System

Applicant Osteomed, LLC

K-Number K202680

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LNH 2020-10-15

SIGNA 7.0T

Applicant Ge Medical Systems, LLC

K-Number K201615

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NKB 2020-10-15

Invictus™ OsseoScrew® System

Applicant Alphatec Spine, Inc.

K-Number K202327

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CDZ 2020-10-15

LIAISON Testosterone xt

Applicant DiaSorin, Inc.

K-Number K201908

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MVL 2020-10-15

STATSTIX

Applicant Centrix Incorporated

K-Number K200764

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KPS 2020-10-15

Cartesion Prime, PCD-1000A, V10.7

Applicant Canon Medical Systems Corporation

K-Number K202349

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IYN 2020-10-15

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K202683

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