7 results
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75ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Extentrac Elite
FDA UDI
Advanced Back Technologies Inc·B727M100·
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
FDA Recall
Terminated
·Advanced Back Technologies, Inc.·Product code ITH·May 13, 2015
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
FDA Recall
Terminated
·Advanced Back Technologies, Inc.·Product code ITH·May 13, 2015
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
FDA Enforcement
Class II
·Terminated·Advanced Back Technologies, Inc.·June 17, 2015
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
FDA Enforcement
Class II
·Terminated·Advanced Back Technologies, Inc.·June 17, 2015
HEMOLUNG RAS
FDA Adverse Event
Death
·ALUNG TECHNOLOGIES, INC.·Product code QLN·January 18, 2023
ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. The device is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease, 2)inflammatory joint disease, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed and 5) treatment of fractures that are unmanageable using other techniques. (For cement use only).
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code JWH·February 19, 2010