10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
BI-METRIC HEAD/NECK HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304222977·
Lacrimal Probe
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896103344·French Pattern Lacrimal Probe Bayonet Shaped Si...
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
FDA 510(k)
FDA Class 2
·Hematology
VIAMO SSA-640A V4.0
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·October 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 14, 2011
CATH-LAB SHEATH INTRO SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DYB·June 6, 2013
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