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

LTT 2017-12-01

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

Applicant Beckman Coulter, Inc.

K-Number K172255

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IYO 2017-12-01

DUS-6000 Digital Ultrasonic Diagnostic Imaging System

Applicant Advanced Instrumentations, Inc.

K-Number K172931

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HRS 2017-12-01

ARIX Humerus System

Applicant Jeil Medical Corporation

K-Number K172008

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IYN 2017-12-01

P10 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K173058

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QEZ 2017-12-01

Octane aspiration system

Applicant Vascular Solutions, Inc.

K-Number K173266

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JWY 2017-12-01

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL

Applicant Thermo Fisher Scientific

K-Number K173209

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NHA 2017-12-01

Straumann n!ce Glass Ceramic A14 Blocks

Applicant Institut Straumann AG

K-Number K171773

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PHX 2017-11-30

Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid

Applicant Zimmer, Inc.

K-Number K172767

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FLL 2017-11-30

Infrared thermometer

Applicant Shenzhen Aeon Technology Co., Ltd.

K-Number K171578

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NKB 2017-11-30

TiLock Modular Spinal System

Applicant Genesys Spine

K-Number K172469

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GZJ 2017-11-30

ReliefBand 1.5

Applicant Reliefband Technologies

K-Number K173233

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MAI 2017-11-30

FIXIT Threaded Anchor System

Applicant S.B.M Sas Science For Bio Materials

K-Number K170868

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