13 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
FDA 510(k)
FDA Class 2
·Neurology
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761976092·Trumpf Medical/Medizin Pad head section 530 G
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761969049·Pad head section 530 G
INTERVENTIONAL BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·February 24, 2017
ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code NIO·July 25, 2017
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code OTN·April 24, 2013
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·July 21, 2008
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·April 22, 2011
HAHN TAPERED IMPLANT Ø4.3 X 10MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 3, 2022
HAHN TAPERED IMPLANT Ø4.3 X 10MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 3, 2022
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014