35 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARi ExCon Implant System
FDA 510(k)
FDA Class 2
·Dental
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017
TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·August 3, 2020
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 11, 2020
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code NKB·February 3, 2010
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code NKB·February 3, 2010
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·December 22, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 26, 2019
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2018
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 2, 2019
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·July 11, 2013
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 2, 2018
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·August 24, 2021
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·August 24, 2021