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

LLZ 2017-04-11

Carestream Vue PACS

Applicant Carestream Health, Inc.

K-Number K170580

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OLZ 2017-04-11

REMbrandt

Applicant Embla Systems

K-Number K163617

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PSZ 2017-04-10

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

Applicant Alere Scarborough, Inc.

K-Number K162642

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MAX 2017-04-10

Keos Lumbar IBFD

Applicant Keos

K-Number K163386

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BTL 2017-04-10

VORTRAN GO2VENT

Applicant Vortran Medical Technology 1, Inc.

K-Number K162968

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IPF 2017-04-10

geko T-2 and geko Plus R-2 Neuromuscular Stimulators

Applicant Firstkind Limited

K-Number K163125

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CGA 2017-04-10

i-Stat Alinity System with i-Stat Glucose test

Applicant Abbott Point of Care, Inc.

K-Number K163271

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MBF 2017-04-10

ARROW Anatomical Porous glenoid

Applicant Fournitures Hospitalieres Industrie

K-Number K162068

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LNH 2017-04-10

Comfort EC710

Applicant Alltech Medical Systems America, Inc.

K-Number K163192

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BTR 2017-04-07

Disposable Endotracheal tube, sterile, AccuCuff

Applicant Tianjin Medis Medical Device Co., Ltd.

K-Number K160694

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CBK 2017-04-07

VOCSN Unified Respiratory System

Applicant Ventec Life Systems, Inc.

K-Number K162877

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JAK 2017-04-07

Philips iCT CT System

Applicant Philips Medical Systems (Cleveland), Inc.

K-Number K162838

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