9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
FDA 510(k)
FDA Class 1
·Radiology
TITANIUM BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL)
FDA 510(k)
FDA Class 1
·General Hospital
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·June 26, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FNL·December 28, 2010
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·February 13, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 1, 2014
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025