13 results
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35ms
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Sources: EU EUDAMED, US FDA
EXTERNAL DEMAND PACEMAKER
FDA 510(k)
FDA Class 2
·Cardiovascular
TABLEPAD, GE AFM, 2 T-FM
FDA UDI
ALIMED, INC.·00733657237856·
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025
BIOFLEX PROFESSIONAL THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
De Mayo Adapt2Fit® Modular Knee Positioner
FDA UDI
Innovative Medical Products, Inc·00696588007700·De Mayo Adapt2Fit® Modular Knee Positioner (w/ ...
De Mayo Adapt2Fit® Modular Knee Positioner
FDA UDI
Innovative Medical Products, Inc·00696588007694·De Mayo Adapt2Fit® Modular Knee Positioner (w/ ...
11.0MM TI HELICAL BLADE 105MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·January 22, 2013
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 9, 2010
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·July 9, 2014
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022