25 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PINNACLE PRECISION ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694014694·1.6mm x 6mm AUTO-DRIVE Screw
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213026131·tmicroSelectron Transfer Tube for 4F Flexibles ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031035·1.6mm x 6mm Auto-Drive Screw, Sterile
TALOS®-T
FDA UDI
SpineArt SA·07640332475867·TALOS-T (HA) LORDOTIC HA PEEK IBFD 6° L28 W10...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321116060·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311116060·
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981319755·16x14x06 Trial Rasp, w/ Depth Stop
MICROMED PD-8K INSULATION DEFECT DETECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PURESPERM BUFFER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694054522·1.6mm x 6mm Auto-Drive Screw Sterile Qty 10
OsteoMed
FDA UDI
OSTEOMED LLC·00845694044028·1.6mm x 6mm AUTO-DRIVE Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040884·1.6mm x 6mm AUTO-DRIVE Screw
Ascendant
FDA UDI
Choice Spine, LP·10885862260789·
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 6, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·June 2, 2011
MICROMAX SYSTEM NOSEPIECE ATTACHEMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT·Product code ERL·August 12, 2008
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001.
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013