64 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
FDA 510(k)
FDA Class 2
·Microbiology
MYSAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
FDA 510(k)
FDA Class 2
·Microbiology
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
NUCLEUS 24 CONTOUR
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·January 15, 2019
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·March 29, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·March 29, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2024
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 29, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·June 9, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
FDA Enforcement
Class II
·Ongoing·AtriCure, Inc.·February 7, 2024
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·June 25, 2024
ACUSNARE POLYPECTOMY SNARE SOFT
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·September 3, 2024
ACUSNARE POLYPECTOMY SNARE SOFT
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·September 3, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·July 26, 2024
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025
ACUSNARE POLYPECTOMY SNARE SOFT
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·April 8, 2024