181 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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MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
FDA 510(k)
FDA Class 2
·Cardiovascular
MAGNETOM TRIO SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
O.B TAMPONS PRODUCTS
FDA Adverse Event
Malfunction
·MONTREAL SAN PRO·Product code HEB·April 17, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 19, 2011
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 20, 2008
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
Total Joint Pack, part number 006358-6
FDA Recall
Terminated
·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
Total Joint Pack, part number 006358-6
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
FDA Recall
Terminated
·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015