19 results
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49ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008021·6mm ID x 6cm length x 210 degrees
ReTAP(TM) Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0005051·8mm ID x 4.5cm length x 230 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008041·7mm ID x 6cm length x 210 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008221·7mm ID x 5cm length x 210 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008081·9mm ID x 6cm length x 210 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008101·10mm ID x 6cm length x 210 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008251·10mm ID x 5cm length x 210 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008241·9mm ID x 5cm length x 210 degrees
ReTAP(TM) Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0005091·10mm ID x 4.5cm length x 230 degrees
ReTAP(TM) Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0005031·7mm ID x 4.5cm length x 230 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008211·6mm ID x 5cm length x 210 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008231·8mm ID x 5cm length x 210 degrees
ReTAP® Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0008061·8mm ID x 6cm length x 210 degrees
ReTAP(TM) Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0005071·9mm ID x 4.5cm length x 230 degrees
ReTAP(TM) Cardiovascular Patch
FDA UDI
SOLINAS MEDICAL INC.·B042FG0005011·6mm ID x 4.5cm length x 230 degrees
RETAP(TM) CARDIOVASCULAR PATCH
FDA Adverse Event
Malfunction
·SOLINAS MEDICAL INC.·Product code DXZ·December 14, 2015
CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·November 23, 2016
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code NKB·June 26, 2014
CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·September 27, 2016