41 results
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56ms
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Sources: EU EUDAMED, US FDA
BIG HEALTH INC
FDA registration
BIG HEALTH INC·2 products·🇺🇸 United States
SleepioRx
FDA UDI
Big Health Inc.·00860008033024·SleepioRx is a digital therapeutic intended for...
BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code NAD·June 9, 2023
BAB FLEXIBLE FABRIC BANDAGES
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·April 18, 2023
PROMOS INCLINATION SET
FDA Adverse Event
Malfunction
·SMITH & NEPHEW·Product code HSD·May 21, 2010
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code POE·August 17, 2021
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·March 19, 2018
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·March 19, 2018
MIC-KEY GASTRIC-JEJUNAL FEED TUBE KIT EXTENSION SETS-22 FR, 2.0 M
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·October 22, 2025
CORGRIP SR NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·August 6, 2024
BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·June 8, 2023
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·March 15, 2018
BAND AID BRAND TRU STAY PLASTIC BANDAGES
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·May 1, 2023
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·February 24, 2025
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 3, 2012
SENSAR IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·June 23, 2023
EASYPUMP 2
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code MEB·March 26, 2025
EASYPUMP 2
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code MEB·March 26, 2025
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·September 16, 2024
640G INSULIN PUMP MMT-1711K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 11, 2023