28 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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BARDPORT TITANIUM PORTS
FDA 510(k)
FDA Class 2
·General Hospital
PULSE
FDA UDI
Nuvasive, Inc.·00195377051530·PULSE Hip Pin Kit, 10cm
Prehma
FDA UDI
Keystone Industries·H66810503101·Sterilization Pouches 3-1/2 X 10 (BX 200)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450405536·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103100·Shaver, Closed, 10mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024052·Paddle Shaver, 10mm
MODIFICATION TO TRIDENT ALL POLY CUP
FDA 510(k)
FDA Class 2
·Orthopedic
VOYAGER 6.0 SOFTWARE OPTION
FDA 510(k)
FDA Class 2
·Neurology
Widex
FDA UDI
Widex A/S·05706069686913·Widex EVOKE E-IP (Dark brown ) 110, Left
Widex
FDA UDI
Widex A/S·05706069686906·Widex EVOKE E-IP (Clay brown ) 110, Left
Widex
FDA UDI
Widex A/S·05706069686890·Widex EVOKE E-IP (Light beige ) 110, Left
AEQ REV II GLENOID BASEPLATE DIA 25MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code PHX·July 1, 2025
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 13, 2025
AEQ REV GLENOID BASEPLATE 29MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 6, 2025
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·March 7, 2013
FORMULA 418 BILLIARY STENT SYSTEM
FDA Adverse Event
Injury
·COOK, INC.·Product code FGE·May 22, 2008
EXCELON TRANSBRONCHIAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code EOQ·April 6, 2011
Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code KWY·November 8, 2005
AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 25, 2024