25 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NUVASIVE COROENT EXTENSURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NUVASIVE
FDA Adverse Event
Injury
·NUVASIVE·Product code NKB·January 10, 2011
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849493·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE LARGE FU...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192152·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0122100·T-Handle, Head Persuader
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO ACCU-CHEK INFORM METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SLEEPEASY
FDA Adverse Event
Injury
·RESPIRONICS INC.·Product code BZD·April 12, 2012
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 6, 2010
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·November 25, 2009
M-SERIES DC POWER SUPPLY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 25, 2012
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 11, 2013
UNKNOWN BONE MORPHOGENETIC PROTEIN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NEK·April 12, 2011
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·May 21, 2008
BASEPLATE IMPACTOR, ASSEMBLY
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·June 11, 2024
BASEPLATE IMPACTOR, ASSEMBLY
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·June 11, 2024
BASEPLATE IMPACTOR, ASSEMBLY
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·June 11, 2024
OUTRIGGER TARGETING GUIDE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·March 21, 2025
REMSTAR PLUS M-SERIES
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·March 16, 2012
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code BZD·February 24, 2010