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

EHD 2016-06-20

BI IMAGE-X EVOLUTION

Applicant Radiotecnologia Industrial S.A. DE C.V.

K-Number K160458

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OAS 2016-06-20

RCT700

Applicant Ray Co., Ltd.

K-Number K160525

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FFX 2016-06-20

Lehman Manometry Catheter

Applicant Wilson-Cook Medical, Inc.

K-Number K160170

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MJN 2016-06-20

REBOA Balloon Catheter

Applicant NuMED, Inc.

K-Number K160598

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KPR 2016-06-20

RADspeed Pro

Applicant Shimadzu Corporation

K-Number K152244

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OMP 2016-06-20

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

Applicant Kci USA, Inc. (Kinetic Concepts, Inc.)

K-Number K160451

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HAE 2016-06-18

Kerrison Rongeurs

Applicant Vitalitec Medizintechnik GmbH

K-Number K152734

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KNS 2016-06-17

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

Applicant Sumitomo Bakelite Co., Ltd.

K-Number K152771

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HIF 2016-06-17

S698 Symbioz flow

Applicant Sopro - Acteon Group

K-Number K153367

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JBF 2016-06-17

BinaxNOW G6PD Test

Applicant Alere Scarborough, Inc.

K-Number K161364

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LLZ 2016-06-17

Quantib Brain 1

Applicant Quantib B.V.

K-Number K153351

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PIF 2016-06-17

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

Applicant Boston Scientific Corporation

K-Number K161003

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