23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HurriChem Device Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
FDA 510(k)
FDA Class 2
·Ophthalmic
PERFUSOR COMPACT WITH FM SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code PHX·February 17, 2026
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·February 12, 2013
BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·December 19, 2018
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·January 28, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014
GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 12, 2013
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·February 15, 2013
UNICEL® DXC 600I SYNCHRON ® ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·January 28, 2013
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·February 26, 2013
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·February 26, 2013
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MQP·November 3, 2017
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MQP·October 30, 2017
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code MQP·November 3, 2017
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code MMI·November 26, 2012
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·February 12, 2013
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·February 12, 2013