8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BIOPSY DEVICE ACCESSORY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABL80 FLEX SP80 CO-OX
FDA UDI
Radiometer Medical ApS·05700699442529·ABL80 FLEX Solution pack CO-OX
HEATWAVE
FDA 510(k)
FDA Class 2
·General Hospital
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
FDA 510(k)
FDA Class 2
·Cardiovascular
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·February 5, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 6, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 18, 2014
Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product Number: 500118200. 510k K944522. Qty Dist. - 4,180. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Prostate Stabilization Set
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code IWJ·September 1, 2009