60 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
FDA 510(k)
FDA Class 2
·Ophthalmic
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
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
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 29, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 10, 2011
PREMIUM PLUS CEEA 21 INST W/O TILT-TOP
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·July 28, 2008
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·October 10, 2014
CAPSTONE SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·November 4, 2010