12 results
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19ms
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Sources: EU EUDAMED, US FDA
PEACE MODEL 100 CUFF MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110874·TIP GUARDS VENTED GREEN PACK OF 100
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SQA, SPERM QUALITY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
TELESCOPE, 10 MM, 0°, QUICK LOCK, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·October 31, 2023
TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code EWY·June 5, 2023
ASR UNI FEMORAL IMPL SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·January 11, 2013
VASOVIEW 7 XB EVH SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 3, 2010
PROMUS PREMIER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 3, 2014
UMBILICAL CATHETER
FDA Adverse Event
Malfunction
·VYGON·Product code FOS·February 17, 2021
TIBIAL INSERT MB SZ 2 LT 6MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 11, 2024
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