82 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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