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

QEP 2019-05-23

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

Applicant Cepheid

K-Number K190441

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CCK 2019-05-23

MaxCap Ped and MaxCap Neo

Applicant Maxtec, LLC

K-Number K182362

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EIH 2019-05-23

KATANA Zirconia Block

Applicant Kuraray Noritake Dental, Inc.

K-Number K190436

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OCX 2019-05-23

ERBEFLO 2 Disposable Tubing System

Applicant Erbe USA, Inc.

K-Number K190469

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MQP 2019-05-23

SYNMESH System

Applicant Depuy Synthes Spine

K-Number K183054

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OVD 2019-05-23

Rampart One Lumbar Interbody Fusion System

Applicant Spineology, Inc.

K-Number K191091

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GEI 2019-05-22

Erbe ESU Model VIO 3 with Accessories

Applicant Erbe Elektromedizin GmbH

K-Number K190823

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IYO 2019-05-22

Bladder Scanner (Models: M2, M2-W, M1, M1-W)

Applicant Suzhou Lischka Medtech Co., Ltd.

K-Number K190769

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DXQ 2019-05-22

RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope

Applicant Wenzhou Renhua Instruments Co., Ltd.

K-Number K190902

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IYN 2019-05-22

HERA I10 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K190444

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GEI 2019-05-22

Soniquence RF Generator and Soniquence Electrodes

Applicant Soniquence, LLC

K-Number K183611

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EOB 2019-05-22

Ambu aScope 4 RhinoLaryngo Slim

Applicant Ambu A/S

K-Number K191080

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