8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CALCITONIN IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GC FUJI COAT LC
FDA 510(k)
FDA Class 2
·Dental
DAVINCI / INTUITIVE SURGICAL
FDA Adverse Event
Injury
·INTUITIVE SURGICAL INC.·Product code NAY·January 30, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 4, 2011
DEPUY ASR XL FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·July 21, 2014
Philips Azurion system; Software Version Number: R3.1;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 28, 2026
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015