11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRC-77tHR
FDA 510(k)
FDA Class 2
·Radiology
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
RUBICON 18 SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RADIUS-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 2, 2015
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
CHARGING SYSTEM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 6, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 9, 2008
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
MPACT DM ACETABULAR SHELL
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·July 31, 2018
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