24 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606401·SPACER 2122455 O25 23.5MM 12 DEG 14X55
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1424550·12mm H x 24mm W x 55mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1224550·12mm H x 24mm W x 55mm L x 0 degrees XLIF
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 45cm x 130°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665023503·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741224550·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X12245580·12mm H x 24mm W x 55mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X122455120·12mm H x 24mm W x 55mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L122455120·12mm H x 24mm W x 55mm L XLIF Trial 12 degree L...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674122455060·
SPIFE LD-12 KIT, MODEL 3338
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 30, 2026
- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·May 21, 2013
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·September 22, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 13, 2011
- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code GEN·May 3, 2013