29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TETRIC CERAM
FDA 510(k)
FDA Class 2
·Dental
TERUMO OVATION SPECTROPHOTOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL 3500 MR-COMPATIBLE PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2019
TSRH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 11, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 10, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 12, 2020
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 12, 2020
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 22, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 6, 2016
301 ELEV.
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code DZA·June 19, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 15, 2013
6949 SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·January 19, 2011
TSRH
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 7, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 22, 2016
TSRH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 12, 2018
TSRH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 15, 2017
TSRH
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 14, 2017