10 results
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18ms
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Sources: EU EUDAMED, US FDA
HYGIENE ADAPTORS
FDA 510(k)
FDA Class 1
·Physical Medicine
ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (AQ)
FDA UDI
STERNGOLD DENTAL LLC·00841549103179·ERA abutments provide a resilient attachment wi...
BD PLASTIPAK LEUR LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 4, 2019
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
SYRINGE NON STERILE 50ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 4, 2020
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 2, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 31, 2012
INTRAMATIC HANDPIECE 10CH
FDA Adverse Event
Injury
·KAVO DENTAL GMBH·Product code EFB·August 16, 2010
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