10,000 results
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82ms
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Sources: EU EUDAMED, US FDA
Medtronic Sofamor Danek USA, Inc.
Manufacturer
🇺🇸 United States·1 Importer
MEDTRONIC SOFAMOR DANEK USA, INC.
FDA registration
MEDTRONIC SOFAMOR DANEK USA, INC.·122 products·🇺🇸 United States
MEDTRONIC SOFAMOR DANEK USA, INC.
FDA registration
MEDTRONIC SOFAMOR DANEK USA, INC.·118 products·🇺🇸 United States
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MJO·April 30, 2014
BRYAN CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MJO·April 30, 2014
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·April 30, 2014
SOLERA DRIVER 4.75 STANDARD MAS
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC. (MSB)·Product code OLO·July 26, 2016
SOLERA DRIVER 4.75 STANDARD MAS
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC. (MSB)·Product code OLO·September 22, 2015
MICRO PITUITARY
FDA Adverse Event
Injury
·GEBRUEDER ZEPF MEDIZINTECHNIK GMBH & CO. KG·Product code LXH·December 10, 2020
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·January 21, 2015
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·February 5, 2014
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·July 3, 2013
INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·July 3, 2013
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·July 3, 2013
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·July 3, 2013
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·July 3, 2013
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·July 3, 2013
INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·July 3, 2013
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·October 17, 2012
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·February 19, 2014