12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nanova Sealant
FDA 510(k)
FDA Class 2
·Dental
SR PIP
FDA UDI
Stryker GmbH·00886385019895·SIZE 1: PIP DISTAL BROACH ASSEMBLY (YELLOW)
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613045173·3K Beaver Style Chuck, Hexagon Handle, Collet U...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045698·PrimaLIF LLIF PEEK Implant, 13mm X 26mm X 30mm,...
GALTSTICK INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN STEM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PHX·December 20, 2021
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 14, 2013
PCA MTK PAT COMP UHMWPE SML OBSOLETE PRODUCT NO
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 15, 2011
FORTE GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQX·September 17, 2008
COMP LK SCR 3.5HEX 4.75X25 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·December 20, 2021
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