10 results
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27ms
·
Sources: EU EUDAMED, US FDA
NT SERIES DIGITAL IMAGE MANAGER
FDA 510(k)
FDA Class 1
·Radiology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221118271·3M™ Victory Series™ Second Molar Bands, 955-232...
Zuma™
FDA UDI
Seaspine Orthopedics Corporation·10889981060572·Trial, 32mm x 25mm x 16mm, 12 Deg
MOOR LASER BLOOD FLOW MONITOR MBF3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·December 23, 2021
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 11, 2013
UNIFY CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 13, 2013
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 31, 2016