11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STAINLESS STEEL SOFT SUTURE WIRE
FDA 510(k)
FDA Class 2
·Orthopedic
Prodigy Adjustable Depth Lancing Device
FDA UDI
Prodigy Diabetes Care, LLC·00384849903556·Prodigy Adjustable Depth Lancing Device
OPAL SEAL
FDA 510(k)
FDA Class 2
·Dental
Precision Casting Solutions Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·February 26, 2014
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 5, 2013
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 7, 2014
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026