34 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Wireless Pain Relieve Device
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 29, 2018
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 29, 2018
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 28, 2018
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331601·IN-OVATION® C Roncone 018 UL/ 3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331101·IN-OVATION® C Base Rx 018 UL/3-3 CS HK
VIDAS® HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JHI·December 13, 2017
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 25, 2016
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SENSITITRE AIM (TM)
FDA 510(k)
FDA Class 2
·Microbiology
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC.·Product code NQO·September 3, 2010
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 15, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 27, 2011
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025
OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·June 19, 2017
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018