12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELASTOMERIC SLEEP APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
ACCUTEX BETA-HCG TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STREP B OIA
FDA 510(k)
FDA Class 1
·Microbiology
FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 8, 2018
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·February 6, 2013
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 4, 2011
BIOMET CC I-BEAM TRAY 71MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 21, 2014
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 16, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 21, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 16, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 21, 2024
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013