9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SURGICAL SUTURE PACKAGE INSERTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515238244·Dunning Elev & Curette, dbl end, 7 3/4
NEXUS TKO-6P LUER ACTIVATED DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
CERACAST-V
FDA 510(k)
FDA Class 2
·Dental
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·January 23, 2013
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-VS·Product code NIM·December 16, 2010
XIENCE PROX EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 11, 2014
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014