22 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Corin Optimized Positioning System (OPS) Plan
FDA 510(k)
FDA Class 2
·Radiology
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·February 12, 2020
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·CORIN AUSTRALIA PTY LTD·Product code LZO·December 9, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019
OsteoMed
FDA UDI
OSTEOMED LLC·00842528128282·3.0 X 38mm Cannulated Headed Screw, T10
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
DUET DRF
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE PRO
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 17, 2014
MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 21, 2013
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FAD·July 28, 2011
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·August 13, 2021
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 27, 2022
HANDLE ACETABULAR PRESS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025