11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·January 2, 2019
STRYKER CASSETTE PUMP
FDA 510(k)
FDA Class 2
·General Hospital
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 2, 2018
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·February 4, 2016
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 1, 2015
SERISCAFFOLD SURGICAL SCAFFOLD (OUS)
FDA Adverse Event
Injury
·ALLERGAN·Product code OXF·October 1, 2014
HOY-PRESENCE LIFT
FDA Adverse Event
Other
·APEX HEALTHCARE MFG INC.·Product code FNG·March 12, 2013
ECLIPSE
FDA Adverse Event
Death
·VARIAN MEDICAL SYSTEMS, FINLAND OY·Product code MUJ·June 17, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024