19 results
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Sources: EU EUDAMED, US FDA
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FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II
Oticon
FDA UDI
Oticon A/S·05707131281340·NERA2, BTE 13 WL 85 DBL
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100189·MCINTYRE SPECULUM CLOSED WIRE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100677·CASTROVIEJO LID SPECULUM MEDIUM
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028796·PESSARY, HODGE #9, W/SUPPORT, 110mm
NEUROSYSTEMS 1TM MONITOR
FDA 510(k)
FDA Class 2
·Neurology
STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 6, 2013
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
NSK
FDA Adverse Event
NAKANISHI INC.·Product code EGS·July 16, 2015
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023