19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CODMAN SKULL CLAMP
FDA 510(k)
FDA Class 2
·Neurology
PROFYLE
FDA UDI
Stryker GmbH·34546540244278·BONE SCREWS, CROSS-FIT, SELF-TAPPING
PROFYLE
FDA UDI
Stryker GmbH·07613153152217·Lid For Sterilizing Container
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120110·Assembly, Screwdriver, Polyaxial, Cannulated, L...
PhoeniX
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO A620 EEG
FDA 510(k)
FDA Class 2
·Neurology
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·November 4, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·November 4, 2011
HOLDING SLEEVE-LONG FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·September 18, 2013
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 18, 2015
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 1, 2010
HERO GRAFT
FDA Adverse Event
Injury
·HEMOSPHERE, INC.·Product code DSY·January 11, 2013
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. REG. # 8010379·Product code LPH·July 3, 2014
2.0 SYSTEM 2.0/1.0 4 HOLE XLONG PLATE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·April 26, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 27, 2015
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·November 4, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·November 4, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·November 4, 2011
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024