20 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Velofix TLIF Cage
FDA 510(k)
FDA Class 2
·Orthopedic
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SERIES TWENTY THOUSAND LEGACY & ACCESSORIES
FDA Adverse Event
Injury
·ALCON LABORATORIES·Product code HQE·December 20, 1996
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2015
VA LOCKSCR Ø2.4 SELF-TAP L12 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 18, 2013
VARIAN CLINAC
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·October 1, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·April 27, 2022
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 30, 2015
SCREW,FIXATION,BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·December 30, 2014
UNK - SCREWS: 2.7 MM VA LOCKING
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·March 1, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 22, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 24, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 1, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 24, 2015
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 23, 2019
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