26 results
·
21ms
·
Sources: EU EUDAMED, US FDA
INSORB ABSORBABLE STAPLES, MODEL SP-B20
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GC FUJI LINING LC PASTE PAK
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO OUTBACK CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 18, 2021
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·March 27, 2013
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 11, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·April 5, 2008
SAFESET¿ TRANSPAC IT W/03 ML RESERVOIR AND SINGLE NEEDLELESS VALVE, WITHOUT VELC
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·May 15, 2023
SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 18, 2021
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2018
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 17, 2019
TL,HINGE, UNIVERSAL
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code LXT·June 18, 2024
SELECTSECURE MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code NVN·November 21, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·May 13, 2026
BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 22, 2020
RELION INSULIN SYRINGE
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·May 4, 2020
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 19, 2020
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 14, 2021
SUREFORM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code GDW·December 21, 2023