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

LLZ 2020-03-13

EzOrtho

Applicant Ewoosoft Co., Ltd.

K-Number K192888

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KNT 2020-03-13

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

Applicant Prosys International, Ltd.

K-Number K193325

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CGA 2020-03-13

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K200349

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NXC 2020-03-12

NEOLab Clear Aligners

Applicant New England Ortho Lab, Inc.

K-Number K192338

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IYE 2020-03-12

RefleXion Medical Radiotherapy System

Applicant Reflexion Medical, Inc.

K-Number K190978

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MRZ 2020-03-12

SpaceStation MRI

Applicant B. Braun Melsugen AG

K-Number K191910

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MBI 2020-03-12

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K200341

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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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