13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTMIX PRE-FILLED MIXING SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809870725·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...
LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CHI·March 4, 2011
SYNCHRON VANCOMYCIN REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011
ADVANCE UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHRON LX 20 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 8, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 2, 2013
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 6, 2011
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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