19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189799·LEVAMED ACTIVE ANKLE SUP BLACK R IV
Sanibel Supply A/S
FDA UDI
Interacoustics A/S·05711117019100·ETB Titan standard electrode cable kit/3pcs (BR...
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278369·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278314·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278321·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278345·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278352·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278338·
RADS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN ORTHOSIS
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017
10NM TORQUE LIMITING HANDLE 6MM HXC
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·March 19, 2013
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011
PURITAN BENNETT
FDA Adverse Event
Injury
·PURITAN BENNETT·Product code CBK·March 10, 2008
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035; 4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040; 2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025; 3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030; 3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035; 4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040; 4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045; 5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050; 5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024