33 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MS SYSTEM (NARROW RIDGE)
FDA 510(k)
FDA Class 2
·Dental
Conformis Hip System
FDA UDI
Conformis, Inc.·00810933030032·REAMER, ACETABULAR, 48MM FULL
DJ ORTHOPEDICS POST SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
FDA 510(k)
FDA Class 2
·Dental
INFINION CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 10, 2024
OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017
OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017
CARDIAC SURGERY PACK BO-TOP 36500
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 28, 2017
CUSTOM TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
CUSTOM TUBING PACKS
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code PAH·April 26, 2013
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 22, 2011
PRGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 22, 2008
BO-TOP 36500 QUADROX OXYGENATOR
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·November 14, 2017
CUSTOM TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017
CUSTOM SURGERY PACK BO-TOP 36500/ QUADROX
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·September 28, 2017
BEQ-TOP 5210 ECC PACK
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·November 9, 2017
CUSTOM PACK BO-T 25102
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017
CUSTOM TUBING PACK BO TOP 25102
FDA Adverse Event
Malfunction
·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017
Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013