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

MQB 2017-06-30

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K163624

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DQX 2017-06-29

Firebow Wire Torque Assist Device

Applicant Vesatek, LLC

K-Number K170684

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PDJ 2017-06-29

ADAMS A1c HA-8180V, CALIBRATOR 80

Applicant Arkray Factory, Inc.

K-Number K162822

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MAX 2017-06-29

SAGICO IBF SYSTEM ARIA LUMBAR, SAGICO IBF SYSTEM ARION CERVICAL

Applicant Spinal Analytics & Geometrical Impant Co, LLC

K-Number K161710

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MXD 2017-06-29

BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set

Applicant Biotronik, Inc.

K-Number K171514

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NKB 2017-06-29

PHA S1 Spinal System

Applicant Phamedica, Inc.

K-Number K163011

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PVQ 2017-06-29

Rickettsia Real-time PCR Assay

Applicant Centers For Disease Control and Prevention (CDC)

K-Number K170940

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FTL 2017-06-29

Parietene DS Composite Mesh

Applicant Sofradim Production

K-Number K163212

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PWD 2017-06-29

ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

Applicant Beckman Coulter

K-Number DEN160047

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DWP 2017-06-29

Vessel Dilator

Applicant Fetzer Medical GmbH & Co. KG

K-Number K163524

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MBF 2017-06-29

SMR Hybrid Glenoid System

Applicant Lima Corporate S.P.A.

K-Number K163397

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FRG 2017-06-29

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

Applicant Ahlstrom Nonwovens, LLC

K-Number K171533

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