14 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARD PTFE (TEFLON) COATED GUIDE WIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·June 11, 2024
8.5MM MEDULLARY REAMER HEAD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·April 29, 2013
SYS 6 RECIP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·April 26, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·July 25, 2008
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·July 3, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·May 9, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
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