11 results · 22ms · Sources: EU EUDAMED, 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