11 results
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17ms
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Sources: EU EUDAMED, US FDA
RULER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135172·
SOMATOMEDIN C BY RADIOIMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SLT 220 WASHER FOR MICROITITERPLATES
FDA 510(k)
FDA Class 2
·Microbiology
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 22, 2013
CONQUEST PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·May 27, 2014
VERSA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·October 5, 2010
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code NEK·November 27, 2012
ASPHERE M SPEC 12/14 40 +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 22, 2013
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022
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