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

CDZ 2019-01-29

FastPack IP Sex Hormone Binding Globulin Immunoassay

Applicant Qualigen, Inc.

K-Number K182521

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IYN 2019-01-29

X5 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K182648

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MAX 2019-01-29

Neo Cage System TM

Applicant Neo Medical SA

K-Number K181048

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DPS 2019-01-28

ZOLL ECG Analysis Software

Applicant Zoll Manufacturing Corporation

K-Number K182093

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IYN 2019-01-28

Aloka Arietta 850

Applicant Hitachi Healthcare Americas

K-Number K183456

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GAM 2019-01-28

WEGO-PGA RAPID

Applicant Foosin Medical Supplies Inc., Ltd.

K-Number K183004

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GAM 2019-01-28

WEGO-PGLA RAPID

Applicant Foosin Medical Supplies Inc., Ltd.

K-Number K183001

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NHA 2019-01-28

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

Applicant Mis Implants Technologies , Ltd.

K-Number K182228

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JDC 2019-01-28

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow

Applicant Zimmer, Inc.

K-Number K181307

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IYN 2019-01-28

Venue GO

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K183362

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MEG 2019-01-28

Greenmedi Safety Filter Syringe

Applicant Sang-A Frontec Co., Ltd.

K-Number K173743

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MAX 2019-01-28

VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System

Applicant Wenzel Spine, Inc.

K-Number K180822

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