9 results
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56ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
FDA Enforcement
Class II
·Terminated·Catheter Connections, Inc.·September 17, 2014
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017
ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
FDA Enforcement
Class I
·Terminated·Hummingbird Med·June 1, 2016
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
FDA Enforcement
Class II
·Terminated·superDimension, Inc·July 18, 2012
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
FDA Enforcement
Class II
·Terminated·Arrow International Inc·September 9, 2015
THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017