11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVANTA GRAFT (>6MM)
FDA 510(k)
FDA Class 2
·Cardiovascular
Monolith
FDA UDI
Nuvasive, Inc.·00887517677419·Monolith Endcap, 19x16mm Lord 10° Ø14
ADVIA® Chemistry MG_c Magnesium Reagents, Concentrated
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414526713·Magnesium - ADVIA Chem. - RGT - 6x1270 tests
MILENIA(TM) PCP
FDA 510(k)
FDA Unclassified
·Unknown
LINDQUIST MODEL SS POWERED MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
TARGET ADAPTER T2 SCN
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012
PFC SIGMA STAB INS SZ3 10MM
FDA Adverse Event
Injury
·DEPUY (IRELAND) 9616671·Product code JWH·March 7, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 7, 2011
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·August 8, 2014
VERSA-DIAL 46X21X50 HUM HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·April 6, 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