10 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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TENAX WHITE POST
FDA 510(k)
FDA Class 1
·Dental
artegral life
FDA UDI
Merz Dental GmbH·D7091993545·anteriors; shade BL1; mould ITM
Corin Optimized Positioning System (OPS) Femoral
FDA 510(k)
FDA Class 2
·Orthopedic
PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·February 26, 2014
WHEELCHAIR COMPONENTS
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code KNN·March 7, 2013
ENDOPATH STEALTH CIR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code KOG·February 16, 2011
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 4, 2022
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024