12 results
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19ms
·
Sources: EU EUDAMED, US FDA
HYDRASORB JOYCE SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED
FDA 510(k)
FDA Class 2
·General Hospital
BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CYLINDER FOAM COVERED ALITEX
FDA UDI
ALIMED, INC.·00733657234671·
CYLINDER FOAM COVERED ALITEX
FDA UDI
ALIMED, INC.·00733657234701·
CYLINDER FOAM COVERED ALITEX
FDA UDI
ALIMED, INC.·00733657234688·
CYLINDER FOAM COVERED ALITEX
FDA UDI
ALIMED, INC.·00733657234695·
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 17, 2014
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·January 22, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 8, 2010
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer
FDA Recall
Completed
·DATEX--OHMEDA, INC.·Product code FMZ·June 6, 2023
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer
FDA Enforcement
Class I
·Completed·DATEX--OHMEDA, INC.·November 6, 2024