8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACUSON SC2000 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814183·GENUMEDI PT SILVER L I
CXDI-40EC
FDA 510(k)
FDA Class 2
·Radiology
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
FDA 510(k)
FDA Class 2
·Immunology
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 11, 2013
TOTAL ASR ACET IMP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 7, 2011
SIGNA 1.5 MRI
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code LNH·September 16, 2008
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024