11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
FDA 510(k)
FDA Class 1
·Cardiovascular
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177485·Modular Trial, 14 x 13 x 10mm, 15 Deg Lordosis
Arthrex®
FDA UDI
ARTHREX, INC.·00888867125582·HEADLESS COMPRES SCRW 2.5X10MM
ENDOCLAMP AORTIC CATHETER
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code DXC·June 23, 2006
ROUND FILTERS W/INDICATOR
FDA Adverse Event
Malfunction
·SPS MEDICAL·Product code FRG·February 28, 2014
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
FDA 510(k)
FDA Class 1
·General Hospital
AESCULAP STERILCONTAINER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 10, 2012
BARD PARKER
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·June 18, 2015
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022