11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BunkerHill BMD
FDA 510(k)
FDA Class 2
·Radiology
15L8 Transducer
FDA UDI
SIEMENS MEDICAL SOLUTIONS USA, INC.·04056869002910·
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)
Alteon
FDA UDI
Exactech, Inc.·10885862517722·ALTEON MONO REVSTM TRIAL SIZE 24X295
Sirius Femoral Stem, Size 30A
FDA 510(k)
FDA Class 2
·Orthopedic
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
FDA 510(k)
FDA Class 2
·Orthopedic
VERSATAP SUTURE ANCHOR
FDA Adverse Event
Malfunction
·ORTHO-DESIGN·Product code MBI·September 15, 2025
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·November 11, 2014
BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·September 10, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
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