13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARIX Femur Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
Portex
FDA UDI
ICU MEDICAL, INC.·15019517110746·
RAYSCAN A-EXPERT 3D
FDA 510(k)
FDA Class 2
·Radiology
SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·December 14, 2023
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 19, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
CELLEX
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·July 8, 2013
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INT'L LTD. 8010379·Product code KXA·November 6, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 6, 2019
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INT'L LTD. 8010379·Product code KWA·November 6, 2019
UNKNOWN HIP FEMORAL AUGMENT
FDA Adverse Event
Injury
·DEPUY INT'L LTD. 8010379·Product code KWA·November 6, 2019
TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 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