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

OAS 2020-11-18

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

Applicant De Gotzen S.R.L.

K-Number K201382

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LLZ 2020-11-18

DBSWIN, VISTAEASY

Applicant Dürr Dental SE

K-Number K203287

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MWP 2020-11-18

TrueView 100 Pro

Applicant Compai Healthcare (Shenzhen) Co.,Ltd

K-Number K202713

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KGO 2020-11-18

Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein

Applicant Medline Industries, Inc.

K-Number K202449

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JAK 2020-11-18

HiRise

Applicant Curvebeam, LLC

K-Number K203187

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PQH 2020-11-18

Liebel-Flarsheim IBP Transfer Set

Applicant Liebel-Flarsheim Company, LLC

K-Number K193010

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IYN 2020-11-18

Venue Go

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K202233

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MAI 2020-11-18

Arthrex FastThread Interference Screw

Applicant Arthrex, Inc.

K-Number K202535

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LIT 2020-11-18

Pacific Plus PTA Catheter

Applicant Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)

K-Number K202800

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MSD 2020-11-18

GlidePath 7.5F Long-Term Dialysis Catheter

Applicant C.R. Bard, Inc.

K-Number K202150

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LLZ 2020-11-17

PROView

Applicant GE Medical Systems SCS

K-Number K193306

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HTY 2020-11-17

VeriFixx Small Bone Implant

Applicant Armis Biopharma, Inc.

K-Number K202777

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