9 results
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11ms
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Sources: EU EUDAMED, US FDA
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
FDA Enforcement
Class III
·Terminated·C.R. Bard, Inc.·August 17, 2016
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
FDA Enforcement
Class III
·Terminated·C.R. Bard, Inc.·August 10, 2016
REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
FDA Enforcement
Class III
·Terminated·C.R. Bard, Inc.·February 24, 2016
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.
FDA Enforcement
Class III
·Terminated·Bard Access Systems·September 5, 2012
PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
FDA Enforcement
Class III
·Terminated·Bard Access Systems·July 15, 2015
PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
FDA Enforcement
Class III
·Terminated·Bard Access Systems·July 15, 2015
PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
FDA Enforcement
Class III
·Terminated·Bard Access Systems·July 15, 2015
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
FDA Enforcement
Class III
·Terminated·C.R. Bard, Inc.·November 11, 2015
PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
FDA Enforcement
Class III
·Terminated·Bard Access Systems·July 15, 2015