14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NobelProcera HT ML FCZ Bridge
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776116019·Slotted U Bracket
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776021764·Slotted U Bracket
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331120985·Slotted "U" Bracket, 12mm, 1.5"
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
NEXGEN FLUTED STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·July 12, 2011
8010042-2008-00099
FDA Adverse Event
Malfunction
·Product code CBK·July 8, 2008
EVOLUT PRO PLUS VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 12, 2023
BD¿ FEMALE LUER LOCK ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 14, 2023
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024