8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PH BLOOD GAS CONTROL PRODUCTS
FDA 510(k)
FDA Class 2
·Hematology
STERILE LASER RESISTANT SURGICAL FIELD DRAPE
FDA 510(k)MODEL 492-01 PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
BIVONA NEO V NECK FLANGE TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·May 14, 2024
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 21, 2012
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·October 27, 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