19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Geomed Vascular Dilators
FDA 510(k)
FDA Class 2
·Cardiovascular
BIFIX SE
FDA 510(k)
FDA Class 2
·Dental
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 28, 2011
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
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
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 23, 2019