17 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REMOTE INFRARED THERMOMETER, MODEL RC002
FDA 510(k)
FDA Class 2
·General Hospital
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
FDA 510(k)
FDA Class 2
·Neurology
K-ASSAY AT-III
FDA 510(k)
FDA Class 2
·Hematology
XIA LP POLYAXIAL SCREW 6.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SSYTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·December 22, 2009
XIA ROD DIA. 6 X 480
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011
XIA BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011
XIA SCREW 6, 5 X 40
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011
XIA LP POLYAXIAL SCREW 5.5 X 45MM
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016
XIA POLYAXIAL SCREW 8.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011
XIA BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
NC QUANTUM APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 16, 2011
XIA LP POLYAXIAL SCREW 6.5 X 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011
SMALL ELECTRIC DRIVE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024