82 results · 24ms · Sources: EU EUDAMED, US FDA

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Catalys Precision Laser System

FDA 510(k)
FDA Class 2 ·Ophthalmic

TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYNGO DYNAMICS, VERSION 6.0

FDA 510(k)
FDA Class 2 ·Radiology

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·February 21, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 16, 2024

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·October 14, 2014

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

FLEXTEND II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 20, 2011

BAKRI TAMPONADE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·March 27, 2018

Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022

BAKRI TAMPONADE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·May 14, 2018

BAKRI TAMPONADE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·December 4, 2018

BAKRI TAMPONADE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·November 5, 2018

BAKRI TAMPONADE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·October 29, 2018

COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·October 2, 2018

COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·November 12, 2018

BAKRI TAMPONADE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·November 15, 2018

COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·November 27, 2018

BAKRI TAMPONADE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·May 1, 2019

COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

FDA Adverse Event
Malfunction ·COOK INC·Product code OQY·April 5, 2019