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

MWI 2017-09-09

All-in-One Health Monitor, PC-303

Applicant Shenzhen Creative Industry Co., Ltd.

K-Number K170047

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PHL 2017-09-08

Indego

Applicant Parker Hannifin Corporation

K-Number K171334

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LIT 2017-09-08

014 Hydrophilic Coated PTA Balloon Dilatation Catheter

Applicant Creagh Medical

K-Number K171251

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LCO 2017-09-08

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls

Applicant Instrumentation Laboratory CO

K-Number K170854

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HWC 2017-09-08

BePOD® EZ Weil Screws

Applicant Fournitures Hospitalieres Industrie

K-Number K163710

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FMF 2017-09-08

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml

Applicant Conceptomed AS

K-Number K171805

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KTT 2017-09-08

The Locking Pediatric Osteotomy Plate (LolliPOP) System

Applicant Pega Medical, Inc.

K-Number K170704

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MWI 2017-09-08

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP

Applicant Fysicon BV

K-Number K170032

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MAX 2017-09-08

Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)

Applicant Bluestone Synergy

K-Number K171893

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MAX 2017-09-08

Posterior Spine Truss System (PSTS) Interbody Fusion Device

Applicant 4Web, Inc.

K-Number K171351

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MBI 2017-09-08

CuffLink Implant System

Applicant Conmed Corporation

K-Number K171725

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HRS 2017-09-08

APTUS(R) Wrist 2.5 System

Applicant Medartis AG

K-Number K172170

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