41 results · 56ms · Sources: EU EUDAMED, US FDA

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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