8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ULCUFLEX HYDROCULLOID DRESSING
FDA 510(k)
FDA Class 1
·General Hospital
3MENSIO WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
INTRA-ARTICULAR SURGICAL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARCHITECT C4000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·July 31, 2018
CE INFUSOR LV10, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 10, 2010
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 17, 2013
PINNACLE 100 ACET CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 8, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021