11 results
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26ms
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Sources: EU EUDAMED, US FDA
CATGUT SUTURE PLAIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
FDA 510(k)
FDA Class 2
·General Hospital
LA-STAPH IDENTIFICATION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FET·July 28, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FET·May 23, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FET·February 4, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FET·September 14, 2021
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2010
GOLD PROBE¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·January 28, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 1, 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