61 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CHI·March 4, 2011
SYNCHRON VANCOMYCIN REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011
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
SYNCHRON LX 20 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 8, 2011
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
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013
EON MINI IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 25, 2011