3,117 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SC90 50 BG, LYT, MET, OXI + QC
FDA UDI
Radiometer Medical ApS·05700699460509·SC90 50 BG, LYT, MET, OXI + QC
3002769706-2015-00155
FDA Adverse Event
Malfunction
·November 30, 2015
VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.
FDA Recall
Terminated
·Biomerieux, Inc.·Product code LSR·October 28, 2003
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·December 4, 2014
I-STAT EG7+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code CHL·September 4, 2025
APPLIANCE, FIXATION, NAIL
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code KTT·December 4, 2014
FULL RING 180MM
FDA Adverse Event
Injury
·SMITH & NEPHEW·Product code LYT·May 6, 2014
EX-FIX
FDA Adverse Event
Injury
·SMITH NEPHEW INC.·Product code LYT·January 13, 2010
PIN
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LYT·October 27, 2014
1020279-2014-00680
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LYT·November 6, 2014
RESOLVE HALO
FDA Adverse Event
Death
·OSSUR AMERICAS·Product code LYT·June 9, 2021
NUT
FDA Adverse Event
Injury
·SYNTHES USA·Product code LYT·October 24, 2012
CAGE
FDA Adverse Event
Injury
·SYNTHES USA·Product code LYT·January 3, 2013
TROCHANTERIC GRIP WITH 2 CABLE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LYT·January 22, 2013
HALF PINS
FDA Adverse Event
Injury
·BROOKS MFG SITE·Product code LYT·October 28, 2009
HIP LINER
FDA Adverse Event
Injury
·HOWMEDICA INTERNATIONAL S. DE R.L/ STRYKER CORP.·Product code LYT·November 21, 2025
TRIGEN
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LYT·June 22, 2009
INTERTAN
FDA Adverse Event
Injury
·SMITH-NEPHEW INC.·Product code LYT·October 28, 2010
UNKNOWN DEPUY FEMORAL ADAPTER BOLT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LYT·March 29, 2011
CUSHING, 19CM (7.50"), 0.7MM
FDA Adverse Event
Malfunction
·J. JAMNER SURGICAL INSTRUMENTS, INC.·Product code LYT·May 3, 2006