9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
PYLORISET
FDA 510(k)
FDA Class 1
·Microbiology
PUR® Waxing Screw Long, 0.050 Hex
FDA UDI
STERNGOLD DENTAL LLC·00841549117404·Cylindrical stainless steel pins threaded at on...
MODIFIED CAPTIA(R) TOXO-M
FDA 510(k)
FDA Class 2
·Microbiology
1 TRANSDUCER FOR COMBISON 310A
FDA 510(k)
FDA Class 2
·Radiology
BIVONA NEONATAL TIGHT TO SHAFT TRACH TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·May 8, 2024
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 23, 2014
EASYPUMP II LT 100-50-S
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL PRODUCTION LTD.·Product code MEB·January 4, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·November 22, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024