33 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606460·MIDMARK CHIC CST 3.25 SOFTCARE PLUS
Conformis Hip System
FDA UDI
Conformis, Inc.·00810933030070·REAMER, ACETABULAR, 52MM FULL
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
FDA 510(k)
FDA Class 2
·Hematology
5F GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
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
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
ENDURANT BIFURCATED STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 22, 2011
ACCU-CHEK COMFORT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·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
Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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