945 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
FDA 510(k)
FDA Class 2
·Anesthesiology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311319120·
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180518977·LIF Shallow Nerve Cobb, 12mm
K131982
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 23, 2024
THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301
FDA 510(k)
FDA Class 2
·General Hospital
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 29, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 16, 2011
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·August 20, 2008
BIPAP PRO BIFLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 2, 2026
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·July 30, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·July 21, 2021
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code MNS·March 30, 2022
REMSTAR SYSTEM ONE 60 SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 31, 2024
REMSTAR SYSTEM ONE 60 SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 19, 2026
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·July 24, 2021
REMSTAR AUTO
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·August 20, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·September 10, 2021
REMSTAR PRO
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·August 20, 2021