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

JWY 2020-03-12

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml

Applicant Thermo Fisher Scientific

K-Number K193538

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NUC 2020-03-12

BioNourish Lubricant

Applicant Good Clean Love, Inc.

K-Number K193448

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GEX 2020-03-12

elysion-pro

Applicant High Technology Products S.L.U

K-Number K193367

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JDQ 2020-03-12

Tritium Sternal Cable Plate System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K-Number K193468

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KGC 2020-03-12

AMT Suture Delivery System

Applicant Applied Medical Technology, Inc.

K-Number K193612

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IYN 2020-03-12

SonoVision Ultrasound Imaging System

Applicant Tissue Differentiation Intelligence, LLC

K-Number K192388

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FOZ 2020-03-12

Health Line CT Midline Catheter

Applicant Health Line International Corporation

K-Number K200263

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DIO 2020-03-12

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

Applicant Medtest DX

K-Number K191638

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FRO 2020-03-11

AC5 Topical Gel

Applicant Arch Therapeutics, Inc.

K-Number K190129

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OQG 2020-03-11

Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

Applicant Kyocera Medical Technologies, Inc.

K-Number K200328

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LNH 2020-03-11

MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192924

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PBF 2020-03-11

KLS Martin Individual Patient Solutions (IPS) Planning System

Applicant KLS-Martin L.P.

K-Number K192979

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