18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIAISON 25 OH VITAMIN D TOTAL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122230·KWire .045x9" (1.1x225mm)
UNIMAX
FDA UDI
PARAMOUNT SURGICALS, INC.·00852647007368·HORIZONTAL PLATE STANDARD 72.5 MM
CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
FDA 510(k)
FDA Class 2
·Cardiovascular
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 9, 2025
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011
STONYBROOK HSP NY NY 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
HERCULES 3 STAGE BALLOON ESOPHAGEAL
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNQ·May 27, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
C21785 IT TREVISO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code GEI·December 14, 2012
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022
CP5 FLOW MODULE
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWA·July 18, 2024
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025