11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MANDREL GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017750·K-Wire, Double Ended, Trocar Point, Diameter 0....
ZOLL IVTM QUATTRO CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·May 1, 2020
MAXAIR SURGICAL HELMET SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GYNECARE TVT EXACT CONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZOLL IVTM QUATTRO CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·August 25, 2020
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KOB·May 2, 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