8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SCALPEL HANDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STORZ/URBAN SURGICAL MICROSCOPE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OB-PH - PH TEST PAPER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 5, 2010
10MM/130 DEG TI CANN PROXIMAL FEMORAL NAIL-340MM/LEFT
FDA Adverse Event
Injury
·SYNTHES·Product code HTY·December 3, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 18, 2015
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 30, 2014
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017