74 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIAN INTERSTITIAL TITANIUM NEEDLES
FDA 510(k)
FDA Class 2
·Radiology
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
FDA 510(k)
FDA Class 2
·Radiology
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
FDA 510(k)
FDA Class 2
·Immunology
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·November 29, 2019
CAPSTONE VERTEBRAL BODY SPACER
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·July 3, 2017
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code KWP·November 14, 2018
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 22, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 22, 2021
PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020
CAPSTONE CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code MAX·November 19, 2015
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·October 26, 2018
CAPSTONE VERTEBRAL BODY SPACER
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code MAX·July 2, 2009
CAPSTONE SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·September 3, 2010
CAPSTONE® SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·April 17, 2014
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·October 18, 2017
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code MAX·December 21, 2009
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIO·May 6, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 16, 2014
VERSYS HIP REVISION FEMORAL STEM
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LPH·May 3, 2011
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 20, 2016