13 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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BonOs Inject Bone Cement; NEO Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131376336·OPN S 1, MINIRITE R LI-ION 2.4G C094
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10
FDA 510(k)
FDA Class 2
·Cardiovascular
SWIFT FX BELLA
FDA 510(k)
FDA Class 2
·Anesthesiology
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·October 30, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
ARTHREX
FDA Adverse Event
Injury
·Product code HRX·March 28, 2008
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023