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

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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MSD 2017-11-30

NexSite HD, Hemodialysis Step Tip Catheter (60cm)

Applicant Marvao Medical Devices, Ltd.

K-Number K171571

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GZI 2017-11-30

Foot Drop System (Model XFT-2001D)

Applicant Shenzhen Xft Medical Limited

K-Number K162718

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GDW 2017-11-30

Disposable Linear Stapler, Disposable Linear Cutter

Applicant Changzhou Kangdi Medical Stapler Co., Ltd.

K-Number K172538

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JWH 2017-11-30

Destiknee™ Total Knee System

Applicant Meril Healthcare Pvt. , Ltd.

K-Number K172936

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LPH 2017-11-30

Birmingham Hip (BH) Dual Mobility Insert

Applicant Smith & Nephew, Inc.

K-Number K171934

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