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

LLZ 2018-07-10

Ceevra Reveal 2.0

Applicant Ceevra, Inc.

K-Number K173274

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JGS 2018-07-10

Synermed ISE Reagents

Applicant Infrared Laboratory Systems, LLC (Dba Synermed)

K-Number K181201

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MUJ 2018-07-10

3D Bolus Software

Applicant 3D Bolus, Inc.

K-Number K180289

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IYE 2018-07-10

Pseudo-Patient

Applicant Rtsafe, Inc.

K-Number K180697

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ITX 2018-07-10

Disposable guides KDNG00

Applicant Koelis

K-Number K180970

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LRK 2018-07-10

Advanced Dental Applicance

Applicant Dasoft Partners

K-Number K172991

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JEY 2018-07-10

TruMatch CMF Titanium 3D Printed Implant

Applicant Materialise NV

K-Number K173039

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KWQ 2018-07-10

Zavation Cervical Plate System

Applicant Zavation Medical Products, LLC

K-Number K181244

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JTN 2018-07-10

HardyDisk AST Plazomicin 30ug (PLZ30)

Applicant Hardy Diagnostics

K-Number K181700

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QKB 2018-07-10

Workflow Box

Applicant Mirada Medical, Ltd.

K-Number K181572

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LPH 2018-07-09

Prime Acetabular Cup System

Applicant Microport Orthopedics, Inc.

K-Number K180798

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FDT 2018-07-09

PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope

Applicant Pentax of America, Inc.

K-Number K181522

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