13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POWERGLIDE MIDLINE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
AF541
FDA UDI
Respironics, Inc.·00606959024595·AF541 Mask with Entrainment Elbow, Leak 2, with...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016415·Foster NH/ Scissor, 8mm jaws, 4 1/2"
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SURGIVISION INC. CLEARPOINT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Widex
FDA UDI
Widex A/S·05706069798647·Widex D-FA P (Titan grey ) Dream 220, Telecoil,...
Widex
FDA UDI
Widex A/S·05706069818789·Widex UNIQUE U-FS (Titan grey ) 220, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069794175·Widex UNIQUE U-PA (Titan grey ) 220, RC coil
TRANSSEPTAL NEEDLE, BRK 1, 71CM
FDA Adverse Event
Other
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 20, 2013
PENUMBRA SYSTEM REPERFUSION CATHETER 032
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·June 9, 2011
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017