18 results · 23ms · Sources: EU EUDAMED, 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