11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Advance Medical Designs, Inc. Sterile Ultrasound Gel
FDA 510(k)
FDA Class 2
·Radiology
MEGA SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809763501319·Multi-Axial Screw Driver
CAP PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
DX-D 300
FDA 510(k)
FDA Class 2
·Radiology
Free-Lock®
FDA UDI
Zimmer, Inc.·00889024034501·
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
SIMPLEX P-JAPANESE TWIN PACK
FDA Adverse Event
Death
·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·September 16, 2008
PCA II PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE PTE. LTD·Product code MEA·September 16, 2005
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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