62 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTIS ZEE AND ZEEGO
FDA 510(k)
FDA Class 2
·Radiology
MODIFIED 650 MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
STERRAD 50 & STERRAD 100S STERILIZERS
FDA 510(k)
FDA Class 2
·General Hospital
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·November 29, 2019
PRECISION NOVI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 13, 2022
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
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
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 23, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 1, 2011
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·October 10, 2014