11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECONOLITH E3000, MODEL 3000 (SW-6)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVIA RETIC PLUS
FDA 510(k)
FDA Class 2
·Hematology
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SONA PILLOW
FDA Adverse Event
Other
·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007
SONA PILLOW
FDA Adverse Event
Other
·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007
ABBOTT SUPERA STENT SELF-EXPANDING
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIP·December 10, 2020
HI-TORQUE COMMAND 18 GUIDE WIRE
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code DQX·September 26, 2023
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 13, 2013
ATN AR SCREW 100MM STERILE
FDA Adverse Event
Injury
·DEPUY ACE S.A. 'R.L.·Product code HSB·May 8, 2008
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·April 5, 2011
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿¿¿¿¿¿ 2089507-149; j)¿¿¿¿¿¿ 2089507-153; k)¿¿¿¿¿ 2089507-154; l)¿¿¿¿¿¿ 2089507-155; m)¿¿¿ 2089507-156; n)¿¿¿¿ 2089507-157; o)¿¿¿¿ K2037DAED; p)¿¿¿¿ K2037DBED; q)¿¿¿¿ K2037DED; r)¿¿¿¿¿ K2037DJED; s)¿¿¿¿¿ K2037DNED; t)¿¿¿¿¿ K2042TTED; u)¿¿¿¿ K2049DC; v)¿¿¿¿¿ K2049DD; w)¿¿¿ K2049DF; x)¿¿¿¿¿ P2037DAED; y)¿¿¿¿¿ P2037DBED; z)¿¿¿¿¿ P2037DED; aa)¿¿ To be provided
FDA Enforcement
Class II
·Ongoing·GE Healthcare·October 16, 2024