21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)
FDA 510(k)
FDA Class 2
·Orthopedic
TRABIS [K173893]
FDA Adverse Event
Injury
·COLIGNE AG·Product code PLR·April 23, 2019
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
FDA 510(k)
FDA Class 2
·Microbiology
NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS
FDA 510(k)
FDA Class 2
·Physical Medicine
GLUCOSE MONITORING SYS/KIT
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
BIPAP VISION
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BYE·May 29, 2013
NA
FDA Adverse Event
Injury
·Product code LKK·February 28, 2007
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·Product code DQX·May 21, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·December 28, 2021
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·July 15, 2024
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·June 29, 2020
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 14, 2024
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·August 19, 2021
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·May 15, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 14, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 17, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 3, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 7, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·October 31, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·January 27, 2022