26 results · 21ms · Sources: EU EUDAMED, US FDA

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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