11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
FDA 510(k)
FDA Class 2
·Microbiology
Distal Centralizer/Centering Sleeve
FDA UDI
Biomet Orthopedics, LLC·00887868542404·
Answer / Impact / Integral Hip System
FDA UDI
Biomet Orthopedics, LLC·00880304253100·
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
FDA 510(k)
FDA Class 1
·General Hospital
SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO
FDA 510(k)
FDA Class 2
·Radiology
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 11, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
LINOX SMART PROMRI S DX 65/15
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·October 20, 2015
3.5MM LC-DCP® DRILL GUIDE NEUTRAL & LOAD
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code FZX·September 16, 2015