11 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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BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
FDA 510(k)
FDA Class 2
·Microbiology
Oticon
FDA UDI
Sbo Hearing A/S·05714464058839·OTICON MORE 2 MINIRITE T C093 DEMO
LEONE SPA
FDA UDI
LEONE SPA·08033707040361·ROTH DB BRACKET 22 BH KIT
2.0/2.4MM FRACTURE SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036036256·2.4MM X-LOCK CROSS-DRIVE SHORT BLADE
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FM-3000 FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·November 28, 2025
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
EON MINI 16-CHANNEL IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 17, 2011
M2A-MAGNUM 42-50MM TPR INSRT-3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2013