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

LHI 2017-10-19

GRI-FILL PERISTALTIC SET

Applicant Laboratorios Grifols, S.A.

K-Number K162216

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GEX 2017-10-19

Discovery Pico, Discovery Pico Plus

Applicant Quanta System Spa

K-Number K172376

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EBG 2017-10-19

PuRE PMMA Disc

Applicant Quest Dental USA Corp.

K-Number K172281

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EFB 2017-10-19

Premium Plus Prophy Air Motor

Applicant Premium Plus International Limited

K-Number K170261

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NPK 2017-10-19

RPM Reinforced PTFE Mesh

Applicant Osteogenics Biomedical, Inc.

K-Number K171774

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EOB 2017-10-19

Medrobotics Flex Robotic System

Applicant Medrobotics Corporation

K-Number K170453

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LJE 2017-10-19

Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe

Applicant Cook Incorporated

K-Number K172527

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CFR 2017-10-19

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

Applicant Abbott Laboratories

K-Number K170316

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LPL 2017-10-18

Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens

Applicant Tangible Science, LLC

K-Number K171125

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MLY 2017-10-18

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray

Applicant Nuance Medical, LLC

K-Number K172203

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LLZ 2017-10-18

Curve Image 2.0 PACS

Applicant Curve Dental, Ltd.

K-Number K173101

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OLO 2017-10-18

Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap

Applicant Stryker Corporation

K-Number K172034

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