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

MWI 2018-12-06

Unity Network ID

Applicant GE Healthcare

K-Number K183116

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LLZ 2018-12-06

Simplicit90Y

Applicant Mirada Medical, Ltd.

K-Number K182016

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MAX 2018-12-06

PATRIOT® Lumbar Spacers, SUSTAIN® Spacers

Applicant Globus Medical, Inc.

K-Number K181357

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MOL 2018-12-06

Synthetic Polyisoprene Lubricated Male Condom - 5 senses

Applicant Sxwell USA, LLC

K-Number K182438

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MQV 2018-12-06

MagnetOs Putty

Applicant Kuros Biosciences B.V

K-Number K181958

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LNH 2018-12-06

AMRA Profiler

Applicant Amra Medical AB

K-Number K173749

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IYN 2018-12-06

Vivid iq

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K181727

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DZE 2018-12-04

NobelZygoma 0°

Applicant Nobel Biocare AB

K-Number K183069

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DHB 2018-12-04

NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

Applicant Hycor Biomedical

K-Number K182479

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IYE 2018-12-04

MOSAIQ Oncology Information System

Applicant Elekta, Inc.

K-Number K183034

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IYN 2018-12-04

6420 Ultrasound System

Applicant Esaote, S.p.A.

K-Number K183191

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HWC 2018-12-04

Healix Compression Screw System

Applicant Nvision Biomedical Technologies, LLC

K-Number K182949

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