8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
STOMA SHIELD ADAPTER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DSP - STAIN PACK
FDA 510(k)
FDA Class 1
·Hematology
CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES
FDA 510(k)
FDA Class 2
·Cardiovascular
LAP-BAND AP ADJUSTABLE GASRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·April 9, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 26, 2012
LIFECARD XL LATIN AM
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·July 14, 2010
Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015