8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Ivotion Base Print
FDA 510(k)
FDA Class 2
·Dental
3.5 MM LCP DISTAL HUMERUS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
TRIDENT 0 DEG INSERT 44MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MRA·August 31, 2011
SM104 MSERIES W5TH WHLOBS3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 18, 2013
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